MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL),  For IM or IV Use, Single Dose 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic,  Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila
Sweet 2 Eat Yellow Peaches; California Tree Fruit; Product of USA;  Packed in the following configurations:  2.5 lb. box, 4-4.5 lb. box  4-4.5 lb box for Trader Joe's  8/2 Clamshell - net weight 2 lbs.  Costco Consumer Box, 5 lbs  Sam's Club consumer box - 4 lbs (Summer Flame)  BJ's 4 lb clamshell  2 lb bag.    Sticker information - Sweet 2 Eat:  94044 Org TR YF Peach  4044 TR Peach;  4038 CA Peach    Varieties include:   August Flame, August Lady, , Autumn Flame,  Bright Princess, Brittney Lane, Candy Flame,  Crimson Lady, Crimson Princess,  Earli Rich, Elegant Lady,  Grand Finale, Henry 2,3 & 4,  July Flame, June Flame, June Flavor, June Time,  Kaweah, King Midas 17, Last Tango., May Princess, O'Henry, , Princess Time, Rich Lady,, Sierra Rich,  Spring Flame 18, 20, 20.5, 21, 22, SU Peach 13, 15, 17, Sugartime, Summer Flame 26, 29. 24, , Summer Zee, Sweet Dream, Sweet Henry, Tra Zee, Vista, Zee Lady, Zee Pride.  Wawona Packing  Cutler, CA.
2.2 millions boxes (20 lbs per box) estimated since 6-2014
Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots  packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.
Sweet 2 Eat White Peaches; California Tree Fruit; Product of USA:    Brand names:  Sweet 2 Eat,  Orchard Perfect, Trader Joe's,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.       Packed in the following configurations:  4-4.5 lb. box  BJ's 4 lb Clamshell  Costco 5 lb box.  Sam's Club consumer box - 4 lbs (Summer Flame)  Sticker information - Sweet 2 Eat:  94041 Org TR WF Peach  4401 - White Peach    Varieties include:  Autumn Snow, ice Princess, Ivory Dutchess, Ivory Queen, Late White Delight, September Snow,  Sierra Snow, Snow Angel, Snow Blaze, Snow Gem, Snow Giant, Snow King, Snow Lady,  Snow Princess, Summer Sweet, White Delight.    Wawona Packing  Cutler, CA.
2.2 millions boxestotal all fruits (20 lbs per box;) estimated since 6-2014
Sweet 2 Eat Yellow Nectarines  California Tree Fruit; Product of USA:    Brand names:  Sweet 2 Eat,  Orchard Perfect, Trader Joe's,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.       Packed in the following configurations:  Sam's Club 4 lb Nectarine Pouch (summer Flare);  Sam's Consumer Box - 4 lbs.  BJ's 4 lb. Clamshell;  Costco Consumer Box - 5 lbs.  Organic 8/2 Clamshell - 2 lbs.  Organic 2 1/2 lb. consumer box;  Trader Joe's 4 lb consumer  - 4-4.5 lbs.  Labels:  94378 - Org TR YF NEC;  4378 TR NEC;  4036 CA Nectarine    Varieties Include:August Bright, August Fire, August Red, Diamond Bright. Diamond Ray,  Fire Sweet,  Grand Bright, Honey Fire, honey May, Honey Royale, Kay Glo,  Late Red Jim, Mango,  Prince Jim, Red Bright,  Red Glenn, Red Jim, Red Roy, ,Rose Bright,  Royal Glo, September Bright NS 21 Super Star, Spring Bright, Spring Fire,  Spring Flare 20, Spring Flare 22, Spring Flare 23, Summer Bright,  Summer Fire , Summer Flare 27, Summer Flare 28, summer flare 30, Summer Flare 31, Summer Flare 35, Zee Fire    Wawona Packing  Cutler, CA.
2.2 millions boxes total all fruit (20 lbs per box); estimated since 6-2014
Sweet 2 Eat White Nectarines, California Tree Fruit; Product of USA:    Brand names:  Sweet 2 Eat,  Orchard Perfect, Trader Joe's,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.       Packed in the following configurations:  Sam's Consumer Box - 4 lbs.  BJ's 4 lb. Clamshell;  4-4.5 lb box;  Costco Consumer Box - 5 lbs.;    .  Labels:  3035 White Nectarine  93035 Organic TR WF NEC;    Varieties include Arctic Pride, Arctic Snow, August Pearl, Candy Pearl Diamond Pearl,Fire Pearl, Giant Pearl,Grand Pearl, Kay Pearl, Majestic Pearl, Summer Pearl, Polar Light, Regal Pearl, Ruby Pearl Snow Flare 21, Snow Pearl, Spring Pearl.    Wawona Packing  Cutler, CA.
2.2 millions boxes total all fruit (20 lbs per box) estimated since 6-2014
Sweet 2 Eat Plums; Product of USA:    Brand names:  Sweet 2 Eat,  Orchard Perfect, Trader Joe's,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.       Packed in the following configurations:  Sam's 3 1/2 lb Clamshell (Black Diamond)Consumer Box - 4 lbs.  BJ's 4 lb. Clamshell;  2 lb. bag.  Labels:  4040 CA Black Plum;  4042 CA Red Plum;  4440 Tree Ripe Plum;  94040 Org Black Plum;  94042 Org Red Plum.    Varieties include:  Black Plum: Angeleno, Black Amber, black Diamond 11, Black Kat, Slack Splendor, Catalina, Earli Queen, Flavor Rich, Friar, Howard Sun, Owen T,, SP-25 Black Giant, Su Plum 11/37, SU Plum 34/36, SU Plum 41/42. SU Plum, 43.  Red Plum: Betty Ann, Fall Fiesta, Fortune, Fruit Punch, Hiromi Red,Joanna Red, John W., Red Yummy, Royal Diamond, September Yummy, Simka, Yummy Beauty  Green Plum: October Sun      Wawona Packing  Cutler, CA.
Pluot: Product of USA:    Brand names:  Sweet 2 Eat, Sweet 2 Eat Organic Orchard Perfect, Trader Joes,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.     Brand names:  Sweet 2 Eat,  Orchard Perfect, Trader Joe's,  Sam's,  Mrs. Smittcamp's,  Harvest Sweet, Wawona,  Costco,  Sweet  O.     Packed in the following configuration:  BJ's 4 lb. Clamshell;  Labels:  3278 Plumcot;  3609 Red Plumcot  3610 Green Plumcot  3611 Black Plumcot.  Varieties include Dapple Dandy, Dapple Supreme. Flavor Fall, Flavor Grenade, Flavor Heart, Flavorosa, Sugar Jewell, Sweet Treat, Crimson Glo.      Wawona Packing  Cutler, CA.
2.2 millions boxes all fruits total all fruit (20 lbs per box) estimated since 6-2014
All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.
Whole Foods Market Dip Peach Salsa, UPC/PLU 029648300000 Whole Foods Market Scale-Salsa Peach, UPC/PLU 96483  Whole Foods Market Peach Salsa MIN, UPC/PLU 96483  Whole Foods Market Peach Salsa XS, UPC/PLU 90614  Whole Foods Market Peach Salsa, UPC/PLU 25023900000  Whole Foods Market Dip Salsa Peach-LG, UPC/PLU 29648300000  Whole Foods Market Salsa Peach, UPC/PLU 29648300000
Sold between June 1 and July 21, 2014 at Whole Foods Stores
The product has the potential to be contaminated with Listeria monocytogenes.
Whole Foods Market FM Grill Tray Peach, UPC/PLU 025994200000
Whole Foods Market Grilled Peaches with Burrata & Balsamic, UPC/PLU 22206300000
Whole Foods Market HSH Kale Barley Peach Salad, UPC/PLU 22442300000
Whole Foods Market Grilled Peaches, UPC/PLU 22703900000
Whole Foods Market HSH Peach Chutney, UPC/PLU 22935500000
Whole Foods Market Scale-Yogurt Cup Peaches and Cream, UPC/PLU 96595
Whole Foods Market Mango Peach Salsa MIN, UPC/PLU 50195 Whole Foods Market Mango Peach Salsa XS, UPC/PLU 58122
Whole Foods Market Cake Slice Chantilly Seasonal, UPC/PLU 21615600000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 24420800000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 28825800000
Whole Foods Market Cake Large Chantilly Peach, UPC/PLU 21617800000;  Whole Foods Market Cake Small Chantilly Peach, UPC/PLU 21617900000;  Whole Foods Market Cake Slice Chantilly Peach, UPC/PLU 21623200000
Whole Foods Market Tart Large Fresh Fruit, UPC/PLU 21633000000;  Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 21633100000, Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 24985200000; Whole Foods Market Tart Fresh Fruit Large, UPC/PLU 14450
Whole Foods Market Cake Large Layer 1/4 Sheet Chantilly, UPC/PLU 21677200000;  Whole Foods Market Cake Individual Chantilly, UPC/PLU 21677400000
Whole Foods Market Sweet Petites 2 For $3, UPC/PLU 21687700000
Whole Foods Market Tart Peach 6'', UPC/PLU 21704100000; Whole Foods Market WF Bakery Tart-Peach 4'', UPC/PLU 20791000000; Whole Foods Market WF Bakery Tart-Peach 9'', UPC/PLU 20791100000; Whole Foods Market WF Bakery Tart-Peach Mini, UPC/PLU 20791200000
Whole Foods Market Pie Large Peach, UPC/PLU 21759600000; Whole Foods Market Pie Small 6'' Peach, UPC/PLU 24032900000
Whole Foods Market Tart Large Galette Seasonal Fruit, UPC/PLU 24987600000
Whole Foods Market Tart Large Square Fruit, UPC/PLU 28893200000; Whole Foods Market Tart Fruit Large, UPC/PLU 20189700000; Whole Foods Market Tart Fruit Large Square, UPC/PLU 20611000000;  Whole Foods Market Tart Fruit Medium, UPC/PLU 26255;  Whole Foods Market Tart Fruit Medium, UPC/PLU 20189800000;  Whole Foods Market Tart Fruit Small, UPC/PLU 20189600000
Whole Foods Market Summer Splash, UPC/PLU 25102000000
Whole Foods Market Peach Nectarine Lemonade, UPC/PLU 25104900000
Whole Foods Market Heirloom Tomato & Peach Salad, UPC/PLU 28353400000/83534; UPC/PLU 20264900000
Whole Foods Market Seasonal Fruit Tart 4'', UPC/PLU 20900400000; Whole Foods Market Seasonal Fruit Tart 6'', UPC/PLU 20900600000  Whole Foods Market Seasonal Fruit Tart 9'', UPC/PLU 20900700000
Whole Foods Market Peaches n Cream Cake 6'', UPC/PLU 20733500000; Whole Foods Market Peaches n Cream Cake 8'', UPC/PLU 20733600000
Whole Foods Market Cake-Peaches Cream 9'', UPC/PLU 20179200000; Whole Foods Market Cake-Peaches Cream 6'', UPC/PLU 20931300000
Whole Foods Market Pie-Peaches and Cream 8in, UPC/PLU 20139000000;Whole Foods Market Pie-Peaches and Cream 4in, UPC/PLU 20628800000; Whole Foods Market WFM Pie-Peaches and Cream Mini, UPC/PLU 20656900000
Whole Foods Market WFM Dess Bar Cobbler-Peach, UPC/PLU 20643100000
Whole Foods Market WFM Dess Bar-Peach Crumble, UPC/PLU 20666800000
Whole Foods Market WF Bakery Parfait-Peach, UPC/PLU 20683800000; Whole Foods Market Peach Parfait, UPC/PLU 20690500000
Whole Foods Market WF Bakery Parfait-Seasonal Fruit, UPC/PLU 20690500000
Whole Foods Market Ramekin Peach, UPC/PLU 20129300000
Whole Foods Market Cobbler Peach, UPC/PLU 20136000000
Whole Foods Market Upside Down Cake-Peach Blueberry, UPC/PLU 25715800000, Whole Foods Market Cake Small Upside Down Peach Blue, UPC/PLU 24632500000
Whole Foods Market HSH Parfait-Blueberry, UPC/PLU 20659600000
Whole Foods Market Smoothie-Immunity Boost 16 oz., UPC/PLU 50172;  Whole Foods Market Smoothie-Immunity Boost 24 oz., UPC/PLU 50173;  Whole Foods Market Smoothie-Immunity Boost 32 oz., UPC/PLU 50174
Whole Foods Market Smoothie-Apple Pie 16 oz (HSH), UPC/PLU 25113; Whole Foods Market Smoothie-Apple Pie 24 oz (HSH), UPC/PLU 2007
Whole Foods Market Smoothie-Peach Pizazz 24 oz., UPC/PLU 50279; Whole Foods Market Smoothie-Peach Pizazz 16 oz., UPC/PLU 50278;  Whole Foods Market Smoothie-Peach Pizazz 32 oz., UPC/PLU 50280
Whole Foods Market Balsamic Chicken Breast & Peaches, UPC/PLU 20254100000
Whole Foods Market BBQ Peach Tempeh, UPC/PLU 20254000000
Whole Foods Market Bleu Peach Pizza, UPC/PLU 20547600000
Whole Foods Market Crispy BBQ Peach Tempeh, UPC/PLU 20253800000
Whole Foods Market Cumin Lime Grilled Peach and Mozzarella Towers, UPC/PLU 20211600000
Whole Foods Market Grilled Peaches and Cream, UPC/PLU 20253700000
Whole Foods Market Grilled Salmon with Peach Ginger Jam, UPC/PLU 20217400000
Whole Foods Market Grilled Salmon with Peach Rosemary Jam, UPC/PLU 20255600000
Whole Foods Market Grilled Shrimp and Nectarine Salad, UPC/PLU 20254100000
Whole Foods Market Grilled Spiced Peach and Kale Salad, UPC/PLU 20213300000
Whole Foods Market Heirloom Tomato and Nectarine Salad, UPC/PLU 20253800000
Whole Foods Market Heirloom Tomato Peach and Mozzarella Salad, UPC/PLU 20253800000
Whole Foods Market Peach Fruit Crisp, UPC/PLU 21222100000
Whole Foods Market Peach Glazed Pork Loin, UPC/PLU 20249000000
Whole Foods Market Peach Stuffed Pork Loin, UPC/PLU 20216400000
Whole Foods Market Peaches, UPC/PLU 21085000000
Whole Foods Market Peaches with Toasted Almonds and Basil (HSH), UPC/PLU 20250100000
Whole Foods Market Peaches, Feta with toasted almonds and Basil, UPC/PLU 20253800000
Whole Foods Market Caramelized Peach, UPC/PLU 20256200000
Whole Foods Market Caramelized Peach with Ricotta, UPC/PLU 20256300000
Whole Foods Market CC HSH Pear Crisp Slaw, UPC/PLU 25730500000
Whole Foods Market FM Sangria Mix LG, UPC/PLU 29690300000
Whole Foods Market Salmon Fillet with Peach Salsa, UPC/PLU 29913800000
Whole Foods Market Peach Basil Glazed Smoked Salmon, UPC/PLU 29074000000
Whole Foods Market Peach Basil Stuffed Blackened Salmon, UPC/PLU 29512800000
Whole Foods Market Peach Basil Stuffed Salmon, UPC/PLU 25179600000
Whole Foods Market Chipotle Peach Turkey, UPC/PLU 29966100000
Whole Foods Market MRH Peach Butter, UPC/PLU 20034900000
Whole Foods Market Tea Hive-Orchard Peach Freeze, UPC/PLU 30868
Whole Foods Market Tea Hive-Peach Julep Sparkler, UPC/PLU 30865
Whole Foods Market Peach Goat Medallion, UPC/PLU 29535400000
Whole Foods Market Tart Galette Peach, UPC/PLU 24070900000
Whole Foods Market Parfait, UPC/PLU 20642800000
Whole Foods Market Peachy Keen Cold Pressed 16 oz, UPC/PLU 29682700000
Whole Foods Market Fruit Kabobs for Grilling, UPC/PLU 29656500000
Whole Foods Market Lime Infused Peaches and Raspberries, UPC/PLU 29178200000
Whole Foods Market Salsa Peach and Cucumber, UPC/PLU 29648300000
Whole Foods Market Peachy Palmer, UPC/PLU 15766
Whole Foods Market 4'' fresh fruit tart decorated with plums, UPC/PLU 0201189005002; Whole Foods Market 6'' fresh fruit tart decorated with plums, UPC/PLU 0201898022000; Whole Foods Market 9'' fresh fruit tart decorated with plums, UPC/PLU 0201897029000
Whole Foods Market Fresh Peachy Keen Juice 16 oz., UPC/PLU 29683800000
Margaret Holmes Mixed Greens 14.5 oz, Distributed by McCall Farms, Effingham, SC
Swollen Cans; Firm received complaints of illnesses due to consumption of recalled products.
Margaret Holmes, Turnip Greens, 14.5 oz, Distributed by McCall Farms, Effingham, SC
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, DC, DE, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA and WI., and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom and Viet Nam.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
344 units worldwide, with approximately 114 units in the United States.
It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Worldwide Distribution-US (nationwide) including the states of  CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
Invacare Perfecto 2 V Oxygen Concentrator   The finished device is packaged as a single unit.  The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device.      Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099.     The serial number range is as follows for the finished device:   14GF053772-14HF032124 (Sequential serial numbers)
It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213.    2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name: TeleFlex Medical; Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Teleflex Medical Item Number: VM29-7112; Lot Number: 100213.     3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt; Instrumed Product Number: 310-21113; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt; CareFusion Item Number: VM29-71131X; Lot Number: 110110.     4) Instrumed Product Name : Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5; Symmetry Surgical Item Number: 20-4205; Lot Number: 050412.     5) Instrumed Product Name: Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #5; CareFusion Item Number: GL804-001; Lot Number: 030313.     6) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; CareFusion Item Number: VM29-7112X; Lot Numbers: 110312, 110411.     7) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: EMMETT HOOK QUICK RELEASE, NO 1, BLUE RF COATED; CareFusion Item Number: GL805; Lot Numbers: 010214, 020314, 110312.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as &quot;Pre-Amendment&quot; devices.
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.
1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9''; Medline Industries Item Number: MDG2480081; Lot Number: 060413.    2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9'', 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213.     3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9''; Boss Instruments Item Number: 46-2974; Lot Number: 070512.     4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412.     5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213.     6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313.     7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810.    2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Boss Instruments Item Number: 46-5195; Lot Number: 060810.     3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4''; Millennium Surgical Item Number: 9-124570; Lot Number: 060810.     4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810.     5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810.     6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4''; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213.     7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4''; Surgical Direct Item Number: SD16450.100; Lot Number: 060810.     8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4''; Surgipro Item Number
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410.    2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213.     3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312.     4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410.     5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410.     6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.
Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 6 1/4'' Retrograde; Symmetry Surgical Item Number: 55-8685; Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 6 1/4'' Retrograde; CareFusion Item Number: 55-8685; Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 6 1/4''; Boss Instruments Item Number: 65-7048; Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Phoenix Instruments Item Number: 155-8680; Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Autobahn Surgical Item Number: 352614A; Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Echo Instruments; Echo Instruments Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Echo Instruments Item Number: 558-690; Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Symmetry Surgical Item Number: 155-8680; Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-0
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
1) Instrumed Product Name: Bunnell Drill, 5 3/4'', w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4''; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311.
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112.    2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112.     3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413.     4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111.     5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413.     6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113.     7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112.     8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Millennium Surgical Item Number: 0-48239; Lot Numbers: 020212, 120312. 2) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Symmetry Surgical Item Number: 57-6305; Lot Numbers: 020212, 100111, 100213, 120312. 3) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Medline Industries Item Number: MDG1806301; Lot Numbers: 020212, 100111. 4) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; CareFusion Item Number: VM85-1261; Lot Number: 100111. 5) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 6) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 7) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 7/32'' OD; Instrumed Product Number: 590-06496; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 7/32'' OD; Millennium Surgical Item Number: 0-48240; Lot Numbers: 010312, 090113, 120312. 8) Instrumed Product Name: Michele Tr
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical,  Boss Instruments, Symmetry Surgical, and CareFusion brand names.
1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212.    2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212.     3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414.     4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211.     5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211.     6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211.
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
1) Instrumed Product Name: Hudson Cerebellar Extension; Instrumed Product Number: 600-00499; Trade Name: Boss Industries; Boss Industries Product Name: Hudson Cerebellar Extension; Boss Industries Item Number: 74-0132; Lot Number: 110411.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
1) Instrumed Product Name: Cushing Perforating, Drill, 3/8'', 10 mm; Instrumed Product Number: 600-00509; Trade Name: Boss Industries; Boss Industries Product Name: Cushing Perforating, Drill, 3/8'', 10 mm; Boss Industries Item Number: 74-0100; Lot Number: 110211.    2) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Symmetry Surgical Item Number: 57-6034; Lot Number: 060212.     3) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Medfix International; Medfix International Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Medfix International Item Number: MF223-1577; Lot Number: 060212.     4) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Stealth Surgical Item Number: SS2122; Lot Number: 060212.     5) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: CareFusion; CareFusion Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; CareFusion Item Number: VM85-1213; Lot Number: 060212, 110313.
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
1) Instrumed Product Name: Cushing Burr, 3/8'', 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 3/8'', 10 mm; Medfix International Item Number: MF223-1592; Lot Number: 060311.    2) Instrumed Product Name: Cushing Burr, 5/8'', 16 mm; Instrumed Product Number: 600-00534; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 5/8'', 16 mm; Medfix International Item Number: MF223-1597; Lot Number: 060311.     3) Instrumed Product Name: Cushing Burr, 3/4'', 20 mm; Instrumed Product Number: 600-00539; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Burr, 3/4'', 20 mm; Stealth Surgical Item Number: SS2133; Lot Number: 060311.
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211.    2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410.     3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211.     4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410.     5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 10 mm; Boss Instruments Item Number: 74-0125; Lot Number: 030305.     6) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 14 mm; CareFusion Item Number: H-0343; Lot Numbers: 110212, 120313.     7) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Medline Industries; Medline Industries Product Name: Hudson Burr, 14 mm; Medline Industries Item Number: MDG1199404; Lot Number: 030213.     8) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 14 mm; Boss Instruments Item Number: 74-0126; Lot Number: 120313.     9) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 600-00566; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 16 mm; Boss Instruments Item Number: 74-0128; Lot Number: 110111.     1
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412.    2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412.     3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211.     4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111.     5) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Perforator Drill, 13 mm; Boss Instruments Item Number: 74-0140; Lot Number: 070412.
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
1) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: D'errico Perforator Drill, 16 mm; Symmetry Surgical Item Number: 57-6076; Lot Number: 110211.    2) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Teleflex Medical; Teleflex Medical Product Name: D'errico Perforator Drill, 16 mm; Teleflex Medical Item Number: P-22893; Lot Number: 110211.     3)  Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: CareFusion; CareFusion Product Name: D'errico Perforator Drill, 16 mm; CareFusion Item Number: VM85-1253.
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411.    2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss InstrumentsItem Number: 74-0144; Lot Number: 060311.
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212.    2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212.     3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212.     4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Boss Instruments Item Number: 74-0120; Lot Numbers: 030112, 110212.
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
1) Instrumed Product Name: Galt Trephine, 5/8''; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8''; CareFusion Item Number: VM85-1273; Lot Number: 120411.
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.
Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 12-661025; Lot Numbers: 040313, 070512. 2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Echo Instruments; Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete; Echo Instruments Item Number: 576-804; Lot Numbers: 050413, 110212. 3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 6-1945; Lot Numbers: 030314, 040313, 050413, 110212. 4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete; Adler Instrument Item Number: ADR1945; Lot Number: 050413. 5) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Surgical Direct; Surgical Direct Product Name: Gardner-Wells Traction Tongs Complete; Surgical Direct Item Number: SD5861.100; Lot Number: 050413. 6) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs Complete; Stealth Surgical Item Number: SS2191; Lot Number: 110212. 7) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Complete; CareFusion Item Number: VM85-1291; Lot Numbers: 030314, 040313, 050413, 050512, 070212, 070512, 110212. 8) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion;
Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical  brand names.
1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Fixation Screws Fixation Screw Non-Springloaded; CareFusion Item Number: NL9506; Lot Numbers: 010113, 020512, 050514, 060213, 070213, 070413, 120413.    2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180; Boss Instruments Item Number: 74-0185; Lot Numbers: 010113, 020512, 060213, 120413.     3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Millennium Surgical Item Number: 6-1948; Lot Numbers: 020512, 070213, 120413.     4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Prezio Health; Prezio Health Product Name: Replacement Screw Non-Springloaded, Traction Tong; Prezio Health Item Number: 85-1296; Lot Number: 020512.     5) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193B; Lot Numbers: 020512, 120413.     6) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-1296; Lot Numbers: 010113, 010412, 020512.
67 replacement screw non-springloaded traction tongs
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412.    2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412.     3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412.     4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412.     5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412.     6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.
49 lock nuts for titanium traction tongs
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.
1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313.    2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments Item Number: 74-0184T; Lot Numbers: 020512, 100512.     3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical Item Number: SS2193AT; Lot Number: 020512.     4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion Item Number: VM85-12955; Lot Number: 050314, 110211, 110313.
22 titanium fixation screws, springloaded
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512.    2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211.     3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312.     4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211.
17 traction tong replacement screws, non-springloaded
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
1) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2''; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2''; CareFusion Item Number: VM85-12015; Lot Number: 011112.    2) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2''; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2''; CareFusion Item Number: NL9516-T; Lot Number: 011112.
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.
Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Pro
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the  CareFusion and Boss Instruments brand names.
1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8''; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8''; Boss Instruments Item Number: 74-1448; Lot Number: 070412.    2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8''; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8''; CareFusion Item Number: VM85-2559; Lot Number: 070412.     3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8''; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8''; Boss Instruments Item Number: 74-1449; Lot Number: 070412.
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.
1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical Item Number: 3-5754; Lot Number: 030212.    2) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Schoitz Tonometer; Symmetry Surgical Item Number: 60-6031; Lot Numbers: 030212, 030413, 040113, 100312, 120113.     3) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Accutome; Accutome Product Name: Schoitz Tonometer; Accutome Item Number: AM0530; Lot Number: 030212, 120113.     4) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Boss Instruments; Boss Instruments Product Name: Schoitz Tonometer; Boss Instruments Item Number: 80-9010; Lot Number: 100312.     5) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Medline Industries; Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case; Medline Industries Item Number: MDG0781649; Lot Number: 030212, 040113, 100312, 120113.
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.
1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed Product Number: 720-55812; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 7.5 grams; Ambler Surgical Item Number: 5754B; Lot Number: 050411.    2) Instrumed Product Name: Schoitz Weights 15.0 grams; Instrumed Product Number: 720-55822; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 15.0 grams; Ambler Surgical Item Number: 5754F; Lot Number: 050411.
Human Cornea, recovered from an ineligible donor, was distributed.
Portions of the lots may contain units with an incorrect lens axis condition.
Blood product, collected from a donor whose travel history was not complete, was distributed.
Blood product, collected from an unsuitable donor, was distributed.
Blood products, collected from ineligible donors, were distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico.
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.
Report received where the Align Radial Stem fractured.
Distributed in the US in the following states:  CA, FL, IL, MA, ME, NY, PA, RI
Oceans Catch All Natural Jonah Crab Combo Meat, Packaged in round plastic containers (tub with snap-on lid), sold refrigerated: 6 ounce, 8 ounce, and 16 ounce
6 ounce: lot number 0104791, with a sell by date before 10/13/14; lot number 0104666, with a sell by date before 10/15/14; 8 ounce: lot number 0104787, with a sell by date before 10/14/14; 16 ounce: lot number 0104806, with a sell by date before 10/14/14; lot number 0104845, with a sell by date before 10/16/14
Product may be be contaminated with Listeria monocytogenes.
Oceans Catch All Natural Fresh Jonah Crab Leg Meat, Packaged in round plastic containers (tub with snap-on lid), sold as refrigerated: 5 ounce, 8 ounce, and 16 ounce
5 ounce: lot number 0104804, with a sell by date before 10/15/14; 8 ounce: lot number 0104665, with a sell by date before 10/13/14; lot number 0104665, with a sell by date before 10/14/14; lot number 0104804, with a sell by date before 10/14/14; lot number 0104842, with a sell by date before 10/16/14; 16 ounce: lot number 0104659, with a sell by date before 10/13/14; lot number 0104665, with a sell by date before 10/14/14; lot number 0104842, with a sell by date before 10/16/14
Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.
BD Insyte Autoguard Catheter   An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
US- 296,800 devices; OUS - 3,250,150 devices
BD Insyte Autoguard may have potential damage along the body of the catheter.
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061  NDC 57613-007-25
Does Not Meet Monograph: Chlorhexidine Gluconate  Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Blood product, with platelet concentration below the specified minimum requirement, was distributed.
Nationwide, including foreign and govt/VA/military consignees.
Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile.   The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal.  A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
US Distribution in states of: VA and PA only.
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected.  This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
Worldwide Distribution - U.S. Nationwide in the states of  AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL,   IN, LA, MA, MD, ME, MI, MN, MS, MT,  NC, ND,  NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA & WV;  International: Australia, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage:  The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
Worldwide Distribution - US Nationwide in the states of  MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513   Product Usage:  Short term percutaneous fluid drainage
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001   Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052   Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005   Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D   Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
ASEPT Peritoneal Drainage System, Ref No. P09080002   Product Usage:  The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004   Product Usage:  Short term percutaneous fluid drainage.
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225   Product Usage:  Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
ASEPT 2000 ml Drainage Bag, Ref No. 622280   Product Usage:  The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches.   The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Potential breach of sterile barrier due to defective product tray.
US Nationwide Distribution in the state of: WV, NY, and FL..
Mammomat Inspiration system:    Product Usage:  mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by  either hard copy film or soft copy workstation.
It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
Platelet product, collected from a donor who disclosed a history of drug use, was distributed.
Platelet product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, was distributed.
Platelet product that did not meet specifications, was distributed.
Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate  0.85 mL 30 mg/mL  Sterile A Solution  Sterile EO Packaging and Cannula  Product of USA    Abbott Healon Duet Dual Pack  0.55 ml OVD  0.85 ml Healon EndoCoat OVD  Contents:   -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate)  -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate)    Part Number:  US: VT585U and 57502000 (packaged in Healon Duet 10290080)  OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080)  OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012)    Healon EndoCoat Device identification:  For Healon EndoCoat, each lot is assigned a unique lot number for traceability.  The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned.  The numbers 1-6 are sequentially increased representing the manufacturing order number.  Example: Lot 024992.     For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha  unique batch number.  The batch number consists of two alphabetic characters followed by five numeric characters.  The first alphabetic character of each batch number designates the manufacturing site.  The second alphabetic character of each batch number shall be sequential numbers starting with 30001.  Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014).
484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally
AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.  The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.
Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
''Everything Bagels'' product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels.   This product has the UPC number 7 17887 23121 1.   The product is labeled in parts: ''***Everything Bagels***Net Wt. 16 oz (1 lb) 454 g***Produced By Schwartz Brothers Bakery Seattle, Renton WA***7 17887 23121 1***Schwartzbros.com***.
Mislabeling.  Product inside a plastic bag actually contains milk but mis-labeled as ''Everything Bagels'' and this label does not declare milk.
Blood products, collected from a donor who should have been deferred due to history, were distributed.
CT, DE, GA, IA, IL, IN, MA, MD, ME, MI, MN, NC, NH, NY, PA, VA, and WI
ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH,  Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021    Packaging:  For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sale: 6-packs of 1 liter bottles and as individual bottles.    For the 50.7 fl oz. (1.5 liter) plastic bottles:  Wholesale: packed in 12 bottles per case. Retail sale: Individual bottles.    For the 20 fl oz plastic bottles: Wholesale: 24 bottle case; 24 bottle tray; 4 - 6 pack trays. Retail sale: Individual bottles and 6-packs (retail).
JUL 22 2014 time NW1 Best by Jul 21 2016;   Jul 23 2014 time NW1 Best by Jul 22 2016;    Jul 24 2014 time NW1 Best by Jul 23 2016; and    Jul 25 2014 time NW1 Best by Jul 24 2016
1.5 L - 10,890 cs, 12 bottles per case; 1L - 14,270 cs, 12 bottles per case; 20 oz. - 5724 cs, 24 bottle per case
Worldwide distribution. US Nationwide and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lativa, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, and Venezuela.
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43.  Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
This field correction involves all models of Silhouette and Sure-T insulin infusion sets.
US 12,400,098 and Internationally 8,266,733
Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).
Pfizer shipped the affected product to 4,447 direct accounts.    No federal government accounts received the affected product directly from Pfizer Inc.
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Worldwide Distribution - US (nationwide) and countries of: Australia and Japan.
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount.      Product Usage:  High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount;      Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler.    Product Usage:  High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
Platelet product, which failed leukoreduction testing, was distributed.
Blood product, labeled as antigen negative but subsequently tested as antigen positive, was distributed.
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N,  due to a labeling inconsistency. The product  lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product  included in the package is the correct 18Ga size. No injuries or illnesses have been reported.
Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
US: Nationwide (AZ, IA, IL, IN, MA, MD, MI, MN, NE, NH, NJ, NV, NY, PA, SC, TN, WI)
Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars.
Orrington Farms Chicken Flavored Broth Base & Seasoning, Low Sodium labels were placed on jars of Orrington Farms Beef Flavored Broth Base & Seasoning, Low Sodium.
US Distribution to states of: CA and FL.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter.  The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function.  The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7.
HeartLight Seafood brand Frozen Yellowfin Tuna Ground Meat (Thunnus albacares), IQF packed in a master carton of 10 x 1 lbs HDPE bags
Product may have high histamine levels and may be unfit for human consumption.
Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and  Internationally to:  SWITZERLAND; CANADA, COLOMBIA,  GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA,  SOUTH KOREA; and SINGAPORE.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis   Usage:orthopedic.
The stem taper on this device is undersized; the gauge point is not deep enough.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis   Usage:orthopedic.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis   Usage:orthopedic.
US Distribution to states of:  TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160.    The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials.     A growth supplement for the isolation of Legionella.
Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
MEVION S250, used for proton radiation therapy.
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction.  This could result in an incorrect dose delivery of no more than 5%.
Houdini, 3 oz Honey Mustard Pretzel Nuggets, item # COM 562
The wrong seasoning was used on the pretzels, which contains whey, that is not declared on the label.
Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. Dallas, TX 75218, www.CheesecakeRoyale.com
Recalled product contains undeclared FD&C Yellow #5 and wheat.
Recalled product contains undeclared walnuts.  Walnut is not listed on the ingredients statement, however pecans are listed as an ingredient.
Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041
Recalled product contains undeclared wheat.
Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042
US Distribution to states of: CA, IN, PA, AL, and NJ.
Trevo Pro 4 Stent Retriever, Model number 80021;  U.S. Indications for use: The Trevo Retriever is intended to restore blood  flow in the neurovasculature by removing thrombus in patients experiencing  ischemic stroke within 8 hours of symptom onset. Patients who are ineligible  for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA  therapy are candidates for treatment.
Lot number/Expiration date: Lot Number 36774: March 2015  Lot Number 36432: December 2014  Lot Number 36757: March 2015  Lot Number 36761: March 2015
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
*** US: AK, ID, OR, WA; *** FOREIGN: Canada
ReadyBath Shampoo Caps, Scented are fabric-lined caps are pre-moistened rinse-free  shampoo caps used to cleanse hair and are individually packaged in a film packet. There are 30 packets per carton.
Product Code: MSC095230.  Lot Number: 14IE0027.   Expiration Date: September 2016.
The shampoo caps may contain broken needles.
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS :      Product Usage:  Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Product Code: 1020;  NDC: 63323-010-20;   Lot Number: 6107992;   Expiration Date: 09/2015
Defective Container: Vials may be missing stoppers.
Germany, Federal Republic of; Switzerland
Plasma products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S;    Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ
Batch No. 2013/12/14, Best before: Jun 8, 2015
Dried Plum Candy contains non-permitted cyclamates,  undeclared benzoic acid and undeclared Yellow #5.
Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITALY, GERMANY, KOREA, FRANCE, SWITZERLAND, ENGLAND, CANADA, MEXICO, HONG KONG, AUSTRALIA, SRI LANKA, GREECE, CHINA, PHILIPPINES, MARTINIQUE, ROMANIA, SPAIN and TURKEY.
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs.  This may result in an incorrect jaw position during treatment, without generating system interruption.
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined
1,687 boxes (each box has 5 doses) which equates to 8,435 doses
Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed.
US Distribution in the state of IN only.
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010    Intended for use as a total knee replacement in patients with knee joint pain and disability.
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699.
Pies labeled in-store did not have the allergen ''walnuts'' declared in a contains statement or in the ingredient list.
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only,  25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
Lack of Assurance of Sterility; improperly crimped fliptop vials