Recalling Firm
American National Red Cross Southeastern Michigan Region
American Red Cross Blood Services Heart of America Region
Oklahoma Blood Institute - Sylvan N Goldman Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United Kingdom, and Viet Nam.
PA, NY, MI, AL, NJ, FL, KY, OH, MN, MA, DE, VT, and MS CA, IN, IL, MD, VA.
US Distribution to the states of : IL, MI, NY, CA, VA and NV.
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Worldwide Distribution -- US and Canada.
Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
Product was distributed to: CA, CO, FL, GA, IA, IL, IN, MD, MI, MN, MO, MS, OH, OR, PA, TN, TX, VA, WI and Puerto Rico
AZ, CO, NH, TX, MS, AL, GA, NC, VA, NY, PA, MO, MN, KY, IL, WA
Nationwide, United Arab Emirates, and Columbia
Product was distributed to: CA, FL, HI, IA, IN, MI, MN, MO, NE, OR, PA, TN, TX, WI, Guam and Puerto Rico.
All consigness are located within the U.S. on a nationwide level. The firm has no listed foreign consignees.
US Distribution to the states of CA, FL, IL, NY, UT and WA.
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
Nationwide Distribution in the states of CO and ME.
Domestic: AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MI, MO, MS, NC, NE NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV. Foreign: None Foreign:
The affected product was at one store location in GA.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
WHOLE PAWS (TM), MAINTENANCE FORMULA, CHICKEN AND BROWN RICE RECIPE, dog food, NET WT 6 LBS, UPC 0 99482 44710 6
Coconut Bun, NET WT. 4 OZ. Product is packaged in an uncoded, plastic bag with green font. MADE BY GOLDEN KING BAKERY, INC. 90 Bowery New York, NY 10013 212-680-0138.
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Bologna & Cheese, Net Wt. 3.00 oz., UPC 7-01248-00309-9, MFG Code 1038; Thick Bologna & Cheese, Net Wt. 4.50 oz., UPC 7-01248-00913-7, MFG Code 258
Chicken Salad on White Bread, Net Wt. 4.00 oz., UPC 7-01248-00104-9, MFG Code 105; Deluxe Chicken Salad on Toast, Net Wt. 5.00 oz., UPC 7-01248-01019-5, MFG Code 1716; Chicken Salad on White, Net Wt. 4.30 oz., UPC 7-01248-01101-7, MFG Code 1817
Combo Sandwich (Ham, Bologna & Cheese), Net Wt. 4.00 oz., UPC 7-01248-00532-0, MFG Code 638
Ham & Cheese on Wheat, Net Wt. 3.00 oz., UPC 7-01248-00827-7, MFG Code 1035; Ham & Cheese on Wheat, Net Wt. 3.80 oz., UPC 7-01248-01095-9, MFG Code 1811
Fresh Bites Pimento Cheese, Net Wt. 3.50 oz., UPC 7-01248-00114-8, MFG Code 115
Turkey & Swiss on Wheat Bread, Net. Wt. 4.00 oz., UPC 7-01248-00531-3, MFG Code 637; Turkey and Swiss on 100% Whole Wheat, Net Wt. 5.25 oz., UPC 7-01248-01062-1, MFG Code 1776
Chicken, Egg and Cheese Biscuit, Net. Wt. 6.10 oz., UPC 7-01248-01003-4, MFG Code 1712
Country Link Sausage (on bun), Net Wt. 3.50 oz., UPC 7-01248-00120-9, MFG Code 121
Jumbo Breakfast (Sausage, Ham, Egg & Cheese on Bun), Net Wt. 5.25 oz., UPC 7-01248-00507. MFG Code 607
Twin Ham Biscuits, Net Wt. 2.50 oz. and 3.00 oz., UPC 7-01248-00124-7, MFG Code 125
Deli Ham and Cheese, Net Wt. 6.00 oz. , UPC 7-01248-00518-4, MFG Code 618
Cheese Cubes with Crackers (Vac Pack), Net Wt. 3.50 oz., UPC 7-01248-00160-5, MFG Code 1049
Ham & Turkey Hoagie, Net Wt. 5.30 oz., UPC 7-01248-00148-3, MFG Code 166
Philly-Style Cheese Steak, Net Wt. 5.75 oz., UPC 7-01248-00194-0, MFG Code 237
Barbecue Chicken (on bun), Net Wt. 4.60 oz., UPC 7-01248-00144-5, MFG Code 162
Double Cheese Dogs, Net WT., 6.40 oz., UPC 7-01248-00802-4, MFG Code 650
Bacon Cheese Burger, Net Wt. 3.50 oz., UPC 7-01248-01049-2, MFG Code 1761; Jumbo Bacon Cheeseburger, Net Wt. 5.20 oz., UPC 7-01248-01080-5, MFG Code 1795; Junior Bacon Cheeseburger, Net Wt., 3.40 oz. UPC 7-01248-01079-9, MFG Code 1794
Grilled Cheese, Net. Wt. 1.65 oz., UPC 7-01248-00883-3, MFG Code 1593
Pork Ribette (on Bun), Net Wt. 6.00 oz., UPC 7-01248-00805-5, MFG Code 653
Skippy Peanut Butter and Grape Jelly w/White Bread Net Wt. 1.50 oz., UPC 7-01248-01114-7, MFG Code 1597
Deluxe Caesar Salad, Net Wt. 3.24 oz.,UPC 7-01248-00946-5, MFG Code 1655; Caesar Salad, Net Wt., 3.25 oz., UPC 7-01248-01028-7, MFG Code 1740; Caesar Salad, Net Wt. 3.25 oz., UPC 7-01248-00623-5, MFG Code 1522
Ham & Cheese Omelet on Toast w/Hash Brown, Net Wt. 7.25 oz., UPC 7-01248-00955-7, MFG Code 1664
Potato Wedges, Net Wt. 5.50 oz. UPC 7-01248-00924-5, MFG Code 1636
Apple Cobbler, Net Wt. 3.75 oz., UPC 7-01248-01041-6, MFG Code 1729
Jello with Fruit, Net Wt. 7050 oz., UPC 7-01248-01026-3, MFG Code 1738
Broccoli & Cauliflower with Buttermilk Ranch Dressing, Net Wt. 2.50 oz., UPC 7-01248-01069-0, MFG Code 1784
Stawberry Yogurt & Granola, Net Wt. 8.50 oz, UPC 7-01248-01040-9, , MFG Code 1752
Robust Spaghetti w/Meat Sauce, Net Wt. 8.00 oz., UPC 7-01248-00806-2, MFG Code 1560
Zesty Chicken Parmigiana w/Spaghetti, Net Wt. 9.50 oz., UPC 7-01248-00808-6, MFG Code 1562
Macaroni & Cheese w/Smoked Sausage, Net Wt. 7.50 oz., UPC 7-01248-01020-5, MFG Code 1717
French Toast w/Sausage, Net Wt. 4.00 oz., UPC 7-01248-00607-5, MFG Code 1506
Cheesy Eggs w/Link Sausage & Dinner Roll, Net Wt. 7.50 oz., UPC 7-01248-00619-8, MFG Code 1518
Bologna and Cheese on White, Net Wt. 4.80 oz., UPC 7-01248-01106-2, MFG Code 1821
Bologna and Cheese Sub, Net Wt. 6.75 oz., UPC 7-01248-01108-6, MFG Code 1823
Chicken Salad on Wheat, Net Wt. 4.00 oz., UPC 7-01248-00809-3, MFG Code 1563; Chicken Salad on Wheat, Net Wt. 4.30 oz., UPC 7-01248-01102-4, MFG Code 1818
Chicken Salad Croissant, Net Wt. 5.75 oz., UPC 7-01248-00918-2, MFG Code 1632
Gourmet Sub (Ham, Bologna & Cheese), Net Wt. 4.00 oz., UPC 7-01248-00307-4, MFG Code 1048
Ham & Cheese on White, Net Wt. 3.00 oz., UPC 7-01248-00301-2, MFG Code 1034; Ham & Cheese on White, Net Wt. 3.80 oz., UPC 7-01248-01096-6, MFG Code 1812; Grilled Ham & Cheese Sandwich, Net Wt. 3.00 oz., UPC 7-01248-00156-8, MFG Code 270
Ham & Cheese on Bun, Net Wt. 3.70 oz., UPC 7-01248-01050-8, MFG Code 1762
Ham & Cheese Club, Net Wt. 6.50 oz., UPC 7-01248-01018-8, MFG Code 1715
Ham & Cheese Croissant, Net Wt. 5.50 oz., UPC 7-01248-01097-3, MFG Code 1813
Ham & Cheese Pretzel Roll, Net Wt. 7.50 oz., UPC 7-01248-01082-9, MFG Code 1798
Shaved Ham & Cheese, Net Wt. 4.00 oz., UPC 7-01248-00100-1, MFG Code 101
Turkey on Wheat, Net Wt. 3.40 oz., UPC 7-01248-00110-1, MFG Code 111
Fried Bologna & Egg on Bun, Net Wt. 5.40 oz., UPC 7-01248-00804-8, MFG Code 652
Sausage & Egg (on bun), Net Wt. 3.75 oz., UPC 7-01248-00130-8, MFG Code 131
Sausage, Egg & Cheese Croissant, Net Wt. 5.00 oz., UPC 7-01248-00523-8, MFG Code 623
Twin Sausage Biscuits, Net Wt. 3.50 oz., UPC 7-01248-00126-1, MFG Code 127
Two 1/2 Foot Ham & Turkey Sub, Net Wt. 11.30 oz., UPC 7-01248-00939-7, MFG Code 1648
Two 1/2 Foot Turkey & Cheese Hoagies, Net Wt. 11.50 oz., UPC 7-01248-00950-2, MFG Code 1659
Barbecue Beef, Net Wt. 4.30 oz., UPC 7-01248-00176-6, MFG Code 294
Chicken Fillet w/Swiss Cheese (on bun), Net Wt. 5.50 oz., UPC 7-01248-00150-6, MFG Code 168
Double Cheeseburger, Net Wt. 5.20 oz., UPC 7-01248-00140-7, MFG Code 158; Cheeseburger, Net Wt. 3.50 oz., UPC 7-01248-00306-7, MFG Code 1037
Fried Bologna Sandwich (on bun), Net Wt. 3.80 oz., UPC 7-01248-00329-6, MFG Code 275
Fried Chicken Leg Quarter w/Bone on Bread, Net Wt. 7.00 oz., UPC 7-01248-01046-1, MFG Code 1758
Fried Chicken w/Bone Sandwich, Net Wt. 9.50 oz., UPC 7-01248-00333-3, MFG Code 284
Fried Red Hot Link w/Cheese on Bun, Net Wt. 3.50 oz., UPC 7-01248-01048-5, MFG Code 1760
Hot Smoked Sausage on Bun, Net Wt. 3.70 oz., UPC 7-01248-010857-7, MFG Code 1769
Single All Beef Hot Dog, Net Wt. 2.50 oz., UPC 7-01248-00172-8, MFG Code 286
Single Plain Hot Dog, Net Wt. 2.50 oz., UPC 7-01248-00837-6, MFG Code 283; Single Plain Hot Dog, Net Wt., 2.10 oz., UPC 7-01248-00837-6, MFG Code 283
Smoking Joe (Smoked Sausage on Bread), Net Wt. 5.25 oz., UPC 7-01248-00122-3, MFG Code 123
Spicy Chicken Sandwich, Net Wt. 5.15 oz., UPC 7-01248-00940-3, MFG Code 1649
Deluxe Chef Salad, Net Wt. 5.10 oz., UPC 7-01248-00944-1, MFG Code 1653; Chef Salad, Net Wt. 5.10 oz, UPC 7-01248-00603-7, MFG Code 1502
Deluxe Garden Salad, Net Wt. 5.80 oz., UPC 7-01248-00945-8, MFG Code 1654; Garden Salad, Net Wt. 5.80 oz., UPC 7-01248-01027-0, MFG Code 1739; Garden Salad, Net Wt. 5.80oz,, UPC 7-01248-00323-4, MFG Code 280
Deluxe Italian Salad, Net Wt. 5.50 oz., UPC 7-01248-00927-4, MFG Code 1596
BBQ Chicken on 100% Wheat Roll w/Baby Carrots, Net Wt. 7.80 oz., UPC 7-01248-010775-5, MFG Code 1792
Ham & Swiss on Sourdough, Net. Wt. 6.10 oz., UPC 7-01248-00916-8, MFG Code 1630
Chicken Finger Sub w/Potato Wedges, Net. Wt. 8.75 oz., UPC 7-01248-00903-8, MFG Code 1619
Ham & Swiss on Sourdough w/Baby Carrots, Net. Wt. 10.30 oz., UPC 7-01248-00957-1, MFG Code 1666
Jumbo Chili Cheese Burger w/ Potato Wedges, Net. Wt. 9.75 oz., UPC 7-01248-00904-1, MFG Code 1620
Sausage & Egg on Croissant w/Hash Brown Patty, Net. Wt. 7.00 oz., UPC 7-01248-00961-1, MFG Code 1670
Chicken Finger Sub w/Honey Mustard Sauce, Net. Wt. 5.35 oz., UPC 7-01248-01015-7, MFG Code 1719
Ham & Turkey on Multi Grain, Net. Wt. 10.00 oz., UPC 7-01248-01016-4, MFG Code 1728
Turkey & Swiss on 12 Grain, Net. Wt. 6.75 oz., UPC 7-01248-01017-1, MFG Code 1714
Egg Salad on White, Net. Wt. 3.30 oz., UPC 7-01248-01103-1, MFG Code 1819
Turkey and Cheese on Wheat, Net. Wt. 3.80 oz., UPC 7-01248-01091-1, MFG Code 1807
Turkey and Cheese on White, Net. Wt. 3.80 oz., UPC 7-01248-01090-4, MFG Code 1806
All American Hoagie w/Turkey Ham, Bologna & Cheese, Net. Wt. 7.75 oz., UPC 7-01248-01087-4, MFG Code 1803
BBQ Pork on Bun, Net. Wt. 5.35 oz., UPC 7-01248-00880-2, MFG Code 1587
Buffalo Chicken Salad on 100% Whole Wheat Roll, Net. Wt. 5.50 oz., UPC 7-01248-01061-4, MFG Code 1775
Deluxe Chicken Salad on 100% Whole Wheat Roll, Net Wt. 5.30 oz., UPC 7-01248-016063-8, MFG Code 1777
Deli Ham and Cheese on Marble Rye, Net Wt. 5.55 oz., UPC 7-01248-01094-2, MFG Code 1810
Grilled Chicken Croissant, Net Wt. 6.00 oz., UPC 7-01248-01098-0, MFG Code 1814
Grilled Chicken Pretzel Roll, Net Wt. 7.00 oz., UPC 7-01248-01082-9, MFG Code 1798
Ham and Cheese Sub, Net Wt. 6.75 oz., UPC 7-01248-01109-3, MFG Code 1824
Oven Roasted Turkey & Cheese on Wheat Sub, Net Wt. 6.50 oz., UPC 7-01248-01112-3, MFG Code 1827
Oven Roasted Turkey Breast on Pretzel Roll, Net Wt. 6.75 oz., UPC 7-01248-01081-2, MFG Code 1797
Sunrise Sandwich (French Toast, Sausage & Egg), Net Wt. 3.60 oz., UPC 7-01248-01059-1, MFG Code 1773
Turkey and Provolone on Marble Rye, Net Wt. 4.55 oz., UPC 7-01248-01088-1, MFG Code 1804
Turkey and Provolone on Whole Wheat Sub, Net Wt. 8.00 oz., UPC 7-01248-01104-8, MFG Code 1820
Turkey and Swiss on Croissant, Net Wt. 5.50 oz., UPC 7-01248-01092-8, MFG Code 1808
Turkey and Swiss Sub, Net Wt. 6.75 oz., UPC 7-01248-01093-5, MFG Code 1809
Blazing Sausage Dog, Net Wt. 5.50 oz., UPC 7-01248-01065-2, MFG Code 1780
Fried Chicken Strips Hero, Net Wt. 5.80 oz., UPC 7-01248-01110-9, MFG Code 1825
Ham and Cheese Omelet on Toast, Net Wt. 5.25 oz., UPC 7-01248-01078-2, MFG Code 1793
Turkey Breast & Bacon on Wheat (Wedge), Net Wt. 4.80 oz. UPC 7-01248-01072-0, MFG Code 1787
Blueberry Crunch Cake, Net Wt. 4.50 oz. UPC 7-01248-01037-9, MFG Code 1749
Cherry Crunch Cake, Net Wt. 4.50 oz. UPC 7-01248-01038-6, MFG Code 1750
Peach Cobbler, Net Wt. 5.10 oz. UPC 7-01248-00848-2, MFG Code 695
Strawberry Shortcake, Net Wt. 5.25 oz. UPC 7-01248-00549-8, MFG Code 648
Carrots with Buttermilk Ranch Dressing, Net Wt. 2.50 oz. UPC 7-01248-01070-6, MFG Code 1785
Celery with Peanut Butter, Net Wt. 2.50 oz. UPC 7-01248-01071-3, MFG Code 1786
Honeydew Melon, Net Wt. 3.75 oz. UPC 7-01248-01074-4, MFG Code 1789
Strawberries, Net Wt. 2.50 oz. UPC 7-01248-01067-6, MFG Code 1782
Ham Omelet with Dinner Roll, Net Wt. 5.80 oz., UPC 7-01248-00855-0, MFG Code 1582
Pancake w/Sausage, Net Wt. 4.50 oz., UPC 7-01248-00628-1, MFG Code 1528
Sausage & Egg w/Rice, Net Wt. 7.50 oz., UPC 7-01248-00609-9, MFG Code 1508
Chicken Tenders, Net Wt. 8.00 oz., UPC 7-01248-00942-7, MFG Code 1651
Ham & Cheddar on 100% Whole Wheat Roll, Net Wt. 5.30 oz., UPC 7-01248-01060-7, MFG Code 1774
Western Omelet, Net WT. 8.25 oz., UPC 7-01248-00650-1, MFG Code 1551
Pimento Cheese on White, Net Wt. 4.30 oz., UPC 7001248-01099-7, MFG Code 1815
Single Hot Dog w/Chili, Net Wt., 3.10 oz., UPC 7-01248-00800-0, MFG Code 285
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
LaBree's Bakery Chocolate Chip Mini Muffins, 12 pack. Net wt. 10 oz. packaged in plastic clamshell. Frozen Product Code: 7778
Gastrotec (Omeprazole 2.28 g / Misoprostol 1.4 mg.)
Platelets Pheresis Leukocytes Reduced Irradiated
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32
Red Blood Cells Leukocytes Reduced Irradiated Washed
Blood and Blood Products for Reprocessing
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 25 mg., packaged in 400-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-400-40. Mfd. for Virbac AH, Inc., Fort Worth, TX.
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 75 mg., packaged in 200-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-402-75. Mfd. for Virbac AH, Inc., Fort Worth, TX.
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 150 mg., packaged in 100-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-404-15. Mfd. for Virbac AH, Inc., Fort Worth, TX.
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate
Market Pantry Brand Dark Chocolate Covered Almonds 9 oz., UPC 085239555644
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Virbac Soloxine (levothyroxine sodium) Tablets, 0.1mg packaged in 250 and 1000 count bottles. NDC 051311-831-25. Virbac AH Inc., Fort Worth, TX.
Virbac Soloxine (levothyroxine sodium) Tablets, 0.2mg., packaged in 250 count bottles. NDC 051311-832-25. Virbac AH Inc., Fort Worth, TX.
Virbac Soloxine (levothyroxine sodium) Tablets, 0.8mg., packaged in 250 and 1000 count bottles. NDC 051311-838-25. Virbac AH, Inc., Fort Worth, TX.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85'' (2.2 m)
Raw Milk Cheddar Cheese, packaged in 8-oz. blocks and 5-lb. loafs.
Obagi C-Cleansing Gel Lot Number: 13D1049 Product/Part Number 362032070544 Fill Size: 1L Expiration Date: 04/2016 For Professional Use Only Obagi Medical C-Cleansing Gel Deeply Cleans to Remove Makeup and Excess Oil 33.8 fl. oz. (1L) Ingredients: water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betain, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), Red 33 (Cl 17200), Yellow 5 (Cl 19140) Not For Retail Sale The Obagi logo is a registered trademark of OMP, Inc. Distributed by OMP, Inc., Long Beach, CA 90806 Product is packaged into a plastic pre-labeled bottle containing all labeling information.
Groove Gluten-Free Chocolate Chip Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00404 6 and 8 52692 00400 8.
Groove Gluten-Free Dark Chocolate Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00405 3 and 8 52692 00403 9.
Groove Gluten-Free Oatmeal Raisin Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00406 0 and 8 52692 00402 2.
Groove Gluten-Free Peanut Butter Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00407 7 and 8 52692 00401 5.
Groove Gluten-Free Dark Chocolate Cookie & French Chocolate Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00406 0 and 8 52692 00403 2
Groove Gluten-Free Peanut Butter Cookie & French Chocolate Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00411 4 and 8 52692 00410 7
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
Quickie Q7 Adult Rigid Wheelchair Model EIR4
Chopped walnuts packaged in 8 oz. (226 g) plastic bags under the Fisher brand.
Pecan cookie pieces packaged in 8 oz. (226 g) plastic bags under the Fisher brand.
Thera Tablets with Beta Carotene Dietary Supplement
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Jumbo, In-shell, Bulk Hazelnuts packed in 50-lb poly weave plastic sacks. No UPC.
Raw, Shelled Hazelnuts, sold in self-serve bulk bins.
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

Code Info
Lot Number: BEST BY TD2 09 NOVEMBER 2014
The recalled lot code is: R4112D Best Before Date: 7/4/2015
material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
Lot Number: 13D1049 Product/Part Number 362032070544 Fill Size: 1L Expiration Date: 04/2016
Lot Number: M-00953 Expiration Date: 06-2015, UPC Code: 3 09040 53961 8

Product Quantity
21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
431/3 fl oz packages and 1,578/6 fl oz package
137/ 3 fl oz packages and 1009/6 fl oz packages
171/3 fl oz packages and 353/6 fl oz packages
116/3 fl oz packages and 243/6 fl oz packages
64/ 3 fl oz packages and 399/6 fl oz packages
38/3 fl oz packages and 470/6 fl oz packages
840 / 50 lb sacks; approximately 42,000 lbs.

Reason for Recall
Blood products, collected using a scale for which the quality control results were not documented, were distributed.
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
A sample of one lot of product was found to contain levels of thiamine below the FDA recommended limit.
The product was found to contain Undeclared Egg based on samplings and analyses by New York State Department of Agriculture & Markets
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe
Unintended detector and gantry movement due to software issues.
Gastrotec, must have an approved new animal drug application to be legally marketed in the United States. Gastrotec is not approved by the FDA.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding unexplained weight loss, were distributed.
Blood products, in which Quality Control and Distribution of products did not meet specifications, were distributed.
Presence of one inoperable ("dead") sensor pad.
Blood products, collected from a donor with a history of high risk behaviors, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, not prepared according to specifications, was distributed.
Blood product, collected from a donor with a history of incarceration, was distributed.
There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
Blood products, labeled with an incorrect expiration date, were distributed.
Blood product, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
Unqualified power assemblies shipped to customers.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
Product includes peanuts which are not declared on the label.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Product missing expiration dates, lot numbers and the presence of a foreign tablet.
Product missing expiration dates and lot numbers
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the cardboard shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is actually MR unsafe but this information is only required to be in the Instructions for Use (IFU).
Potential for failure of the pouch packaging seal at high altitudes.
Product may be contaminated with Listeria monocytogenes
The firm is conducting a recall of Obagi C-Cleansing Gel 1L lot #13D1049 product/part number 362032070544 expiration date 04/2016 due to the product Obagi Gentle Cleanser lot #13D1049 being packaged in the pre-labeled C-Cleansing Gel bottles in error.
Groove Gluten-Free Ice Cream Sandwich products are recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains custard ice cream base, produced and recalled by Snoqualmie Gourmet Ice Cream, Inc., as an ingredient.
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.
Product may be contaminated with Salmonella
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
Product recalled due to the finding of Salmonella.
Product confirmed positive result for Salmonella.
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Certain product codes and lot numbers of the Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch&reg; Dressing were packaged with the incorrect size Biopatch&reg; Dressing. No risk to patients is anticipated.
In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.