Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
CRN Crono Syringe CRN20 with 19G x 1 ''Steel Needle''
Product Code CRN20, lot numbers 14N02, 15E01, 15A02
Product has the potential to have a clear debris on the tip of the needle.
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT,  DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers.    It is used to detect or image the distribution of radionuclides in the body or organ.
Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
e.cam line of gamma camera systems    Used to detect or image the distribution of radionuclides in the body or organ.
Reports of loose bolts in the detector support structure of Symbia and e.cam systems.
Product was distributed in CT, IN, MD, OH, PA and WV.
Wild'erb Seasoning 2 oz and 4 oz plastic jars; seasoning contained less than 1% sassafras leaves.
The firm was notified by the Ohio Department of Agriculture that Sassafras Leaves may be an illegal ingredient for their product.
Wild'erb Herbal Tea 1.2 oz. and 4 oz. paper bags, tea contained less than 5% sassafras leaves.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MD, MN, MO, NC, NJ, NY, OH, ON, OR, PA, TN, TX, WA, WI, and Canada.
SWISS CHOCOLATE CHOCOLAT ALPROSE 52% CACAO PREMIUM DARK CHOCOLATE, within stand-up maroon colored gift box.  NET WT 3.5 oz (100g).  Packed as a carton containing 6 boxes x 20 units.  UPC 689423025038.  Product of Swtizerland.  Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 11205.
BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen.
Alprose Swiss Chocolate Dark Chocolate within a gold colored pillow gift box. NET WT 3.5 oz (100g). Packed as a carton with 6 boxes x 20 units.  UPC 689423027308.  Product of Switzerland.  Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 12205.
CHOCOLAT Alprose NAPOLITAINS SWITZERLAND, NET WT. 1 Kg (35 oz).  Product packed as the following: 1) bulk in clear plastic bags, 230 pieces with gold, black  and white labeling, each carton contains 6 x 1 Kg bags, 2) 100g packages (3.5oz/~24 pieces.  UPC 712963000354.  Produced in Switzerland for: GROSS & COMPANY INTERNATIONAL, LONDON UK.  US Importer: BBM CHOCOLATE DISTRIBUTORS, BROOKLYN, NY 11205.
Nationwide through internet mail order sales and to NY retail stores
OSCAR'S SMOKE HOUSE JALAPENO PEPPER CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
Products were recalled due to potential Listeria monocytogenes contamination.
OSCAR'S SMOKE HOUSE CHEDDAR SPREAD & BLUE CHEESE, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE CHAMPAGNE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE GARLIC CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE PORT WINE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE TANGY HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE PLAIN CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE ''MORE THAN'' CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE HICKORY SMOKED CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE BACON & HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
OSCAR'S SMOKE HOUSE BACON CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated.  Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC,   Distributed by: Rugby Laboratories Livonia, MI 48150,  NDC 0536-3606-96   Major Children's Mapap Suspension Liquid, Cherry Flavor,  4 FL OZ bottle, OTC,  Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
All Raw Vegan, Raw Carob Powder, Net Wt. 8 oz. and 5 lb bag, - Keep Cool & Dry. Glaser Organic Farms, Miami, FL. (305) 238-7747. UPC Code: 83291005567
Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination.
All Raw Vegan Certified Organic Carob Fudgy Brownie, Net WT. 5.5 oz. (156 g) - Keep Cool & Dry. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. UPC Code: 832910002061.
All Raw Vegan Carob Pudding Pie, Net WT. 4.0 oz. - Keep  Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747.
All Raw Vegan Carob Coconut Raspberry Raw Fruit Pie, Net WT. 8.0 oz. - Keep  Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747.
Nationwide distribution.  No product was distributed to  foreign or U.S. government military and/or civilian units.
Papetti's Table Ready Refrigerated pre-cooked scrambled eggs with butter flavor.  Keep refrigerated 33 - 40 degrees F.  Packaged in 12- 1.85 pound bags with Net Wt. 22.2 lbs (10.06 kg).  Product code:  46025-85877.  UPC Code:  1 07 46025 85877 2.
Lot Nos. with exp. date:   Lots 4156L-4184L with exp. dates 8/28-9/25/2014;  Lots 4188L-4234L with exp. dates 9/29-11/14/2014;  Lot 4237L with exp. date 11/17/2014; and  Lot 4238L with exp. date 11/18/2014
Product may be contaminated with spoilage microorganism.
Papetti's Table Ready Refrigerated pre-cooked scrambled eggs.  Keep refrigerated 33 - 40 degrees F.  Packaged in two different size configurations:   (1) 12- 1.85 pound bags, Net Wt. 22.2 lbs (10.06 kg).  Product code:  46025-85878.  UPC Code:  1 07 46025 85878 9, and    (2) 8- 3.25 lb bags, Net Wt. 26 lbs (11.79 kg).  Product code:  46025-85858.  UPC Code:  1 07 46025 85858 1.
Lot Numbers with Exp. dates for the following packaging configurations:   Product code:  46025-85858, packaged as 8 / 3.25 lb. bags per case:    4169L, exp. date 9/10/2014;  4204L, exp. date 10/15/2014; and   4226L, exp. date 11/6/2014.    Product code:  46025-85878, packaged as 12 / 1.85 lb. bags per case:    4169L, exp. date 9/10/2014;  4190L, exp. date 10/1/2014;  4204L, exp. date 10/15/2014; and  4226L, exp. date 11/6/2014.
Nationwide and to Korea, Chins, Indonesia, Singapore, Malaysia, hong Kong, Mexico and Bermuda.
Plum Organics Little Cremes: Organic Rice Milk Snacks;  Super Greens: Kale, Apple and Sweet Potato;  Net Wt. 1 oz. (28 grams)  8 CT. USDA Organic; Dairy Free.  Ingredients:  ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC DRIED KALE, ORGANIC APPLE FLAVOR, ORGANIC CINNAMON.    Plum Inc.,   Emeryville, CA 94608
Item number 1559; Seling unit UPC 846675000330;  Case UPC: 84665001559;  All codes and sell by dates of BB 05 AUG 14 to 12Aug 15.
Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.
Plum Organics Little Cremes: Organic Rice Milk Snacks;  Super Purples: Acai, Blackberry and Purple Carrot;  Net Wt. 1 oz. (28 grams)  8 CT. USDA Organic; Dairy Free.  Ingredients:  ORGANIC SWEET POTATO PUREE, ORGANIC BLACKBERRY PUREE, ORGANIC APPLE PUREE, ORGANIC ACAI PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC PURPLE CARROT JUICE CONCENTRATE, NATURAL FLAVOR.     Plum Inc.,   Emeryville, CA 94608
Item number 1542; Seling unit UPC 846675000347;  Case UPC: 84665001542;  All codes and sell by dates of BB 05 AUG 14 to 12Aug 15..
Plum Organics Little Cremes: Organic Rice Milk Snacks;  Super Reds: Pomegranate, Beet and Berry;  Net Wt. 1 oz. (28 grams)  8 CT. USDA Organic; Dairy Free.  Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC BEET JUICE CONCENTRATE      Plum Inc.,   Emeryville, CA 94608
Item number 1535; Seling unit UPC 846675000323;  Case UPC: 84665001535;  All codes and sell by dates of BB 05 AUG 14 to 12Aug 15..
soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ  Creepy Peepers  Lot/Code Date: 066113  UPC 00041269503734   MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT BUTTER AND ALMONDS    Inside plastic bag:  Foil wrapped balls  with appearance of an eyeball. On back of candy, labeled:  ''peanut butter''
Product contains undeclared peanut butter. Peanut butter coated chocolate balls packed in bags labeled as Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs
Worldwide Distribution - US including CA and Internationally to CA.
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.
Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
alcosulph Moisturizing Cream, Net Contents: 60g.  Product packaged within a plastic container individually placed in small carton.  Country of Origin Guyana.
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL.  Product packaged within a glass container individually placed in small carton.  Country of Origin Guyana.
MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
Ferrol EXPECTORANT, Net Contents: 100 mL.  Product packaged within a plastic bottle individually placed in small blue carton.  Manufactured by: NEW GPC INC. A1 Farm, EBD.  Country of Origin Guyana.
WHITFIELD LOTION, Net Contents: 60 mL.  Manufactured by: NEW GPC INC. A1 Farm, EBD.  Country of Origin Guyana.
Whitfield's OINTMENT B.P., Net Contents: 15g.  Manufactured by: NEW GPC INC. A1 Farm, EBD.  Country of Origin Guyana.
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.
Rector's Remedy OINTMENT, Net Contents: 15g.  Manufactured by: NEW GPC INC. A1 Farm, EBD.  Country of Origin Guyana.
Does Not Meet Monograph:  NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Worldwide Distribution - USA including US: AL,  AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm  REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm  REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm  REF 3844- Everest BiCOAG LP Scissors 5mm/45cm  REF 910010PK- PKS MOLly Forceps 5mm/45cm    Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
All product manufactured before July 28, 2014.
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients.    The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use.     The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
FRIWO AC/DC Adapter Model Number: GPP10;    The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:     1) Model Number: 1079422; Lot Numbers: 9070140620088 ,  9070140723088 ,  9070140723088;   2) Model Number: 1082693; Lot Numbers: 9073140618134;   3) Model Number: 1082694; Lot Numbers: 9074140530079
FRIWO AC/DC Adapter Model Number: GPP10;    The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:     1) Model Number: AG-UC1000-NE; Lot Numbers: 9263140718116 ,  9263140718137 ,  9263140730049;   2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 ,  9235140718093 ,  9235140718154;   3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 ,  9264140627100 ,  9264140721112 ,  9264140724100;   4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040;   5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046
Distribution was to foodservice customers in AZ, CA, CO, GA, IA, IL, LA, MN, MO MT, ND, NE, NM, PA, TN, TX, WA, and WI.  Product was distributed in Canada.
Frozen battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels:   (1) Imperial Sysco 3/8'' Battered Onion Rings, Distributed by Sysco Corporation, Houston, Texas 77077-2099, Product no.: 41010044, and UPC code:  074865 84822 0;  and  (2) KickStarts Batter Dipt Onion Rings, Net Wt. 40 oz (2.5 lb), Distributed by Food Services of America, Inc., Seattle, WA 98106, Product no. 10210070, UPC 0 41493 49025 0;  and  (3) McCain Onion Rings, Net Wt. 3.18 kg, packaged as 8 x 397g boxes, Product of U.S.A., Prepared for:  McCain Foods (Canada) A Division of McCain Foods Limited, Florenceville-Bristol, New Brunswick, Canada E7L 1B2,  Product No. 1000001362, UPC 0 55773 00089 4.
Frozen beer battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels:   (1) Intros Appetizers & Snacks Beer Battered Thin Cut Onion Rings, Marketed by Independent Marketing Alliance, Houston, Texas 77079, Product no.: 5791088, and UPC code:  8 22468 13390 0;    and     (2) Freddy's Onion Rings, Net Wt. 40 oz (2.5 lb), Packed for Freddy's Frozen Custard & Steakburgers, Wichita, KS 67206, Product no. 100000640, UPC 0 72714 00081 2.
Worldwide Distribution - USA (nationwide) and Internationally to Serbia.
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803    The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period.  If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes.  In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in the instructions for use are incorrect.  The corrected voltage range is 12-30V.  The product is marketed for vehicle systems operating at 12 V and 28V.
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Blood product, collected from a donor who lived in a malarial endemic area, was distributed.
American National Red Cross, Greater Ozark-Arkansas Region
Plateletpheresis product, which failed a monthly product QC test, was distributed.
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Catalog No. ASK-05501-AFH1       Lot Number 23F13K0969
Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, G
Mindray DS USA, Inc. dba Mindray North America
Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation,  Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1   The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.
Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.
Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates  Argentina  Austria  Australia  Aruba  Belgium  Bahrain  Bolivia  Brazil  Bahamas  Canada  Switzerland  Chile  People's Republic of China  Columbia  Costa Rica  Cyprus  Czech Republic  Germany  Algeria  Estonia  Egypt  Spain  Finland  France  Gabon  Great Britain  French Guiana  Greece  Guatemala  Hong Kong  Croatia  Hungary  Ireland  Israel  India  Iran  Italy  Jordan  Kenya  Kuwait  Kazakhstan  Lebanon  Lithuania  Luxembourg  Latvia  Mauritius  Mexico  Malaysia  Mozambique  New Caledonia  Nigeria  Netherlands  Norway  New Zealand  Oman  Panama  Peru  Poland  Palestine  Portugal  Reunion  Romania  Serbia  Russian Federation  Rwanda  Saudi Arabia  Sweden  Singapore  Slovenia  Slovakia  Tunisia  Turkey  Trinadad And Tobago  Taiwan  Ukraine  Uruguay  Venezuela  Mayotte  South Africa
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730  Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
All lots  with expiration on or before August 2017 (2017-08)
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System)  Catalog Number: 82-1731  Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
Codman Lumbar Drainage Catheter Kit II with EDS  3 (External Drainage System) Catalog Number: 82-1738  Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
Blood product, not prepared in accordance with standard operating procedure, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, for which donor suitability was not fully determined, was distributed.
Plateletpheresis product, labeled with an incorrect volume, was distributed.
Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico,  and U.S. - Virgin Islands.  OUS countries to include:  Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103,  F110, F111. Sterilized using ethylene oxide.    Product Usage:  This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low voltage (LV) capacitor.
Worldwide Distribution-USA (nationwide) and the countries of  Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and  Yemen.
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733   Siemens Material Number: 10309508    The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Lot Number: 100064  Exp.Date:February 10, 2015
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733  Siemens Material Number: 10309508    The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. ---  NDC 0456-1420-07
Failed Dissolution Specification; at the 6-month stability time point
Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
The affected products are missing polar boss threads.
Blood product, that did not meet homologous criteria, was distributed.
Blood product, that did not meet allogeneic criteria, was distributed.
President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0
Product contains undeclared sesame seeds
Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan,  Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka,   United Republic of Tanzania, Thailand, Vietnam, Zimbabwe,   Republic of Korea, and Netherlands.
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits   Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery.  Additionally, if a battery is not present or is depleted the ventilators will not operate.  This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL  60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA  92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL  60045.
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only.  2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only  general hospital
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only,   general hospital
Worldwide Distribution: US (nationwide) and internationally to Canada.
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD.   For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 .  Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.
Red Blood Cells Deglycerolized Leukocytes Reduced
Blood product, labeled with incorrect expiration date, was distributed.
Plateletpheresis products, collected in a manner that may have compromised sterility of the units, were distributed.
Misbranded Red Blood Cells were distributed.
Worldwide Distribution-USA (nationwide) and the countries of  AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
Philips IntelliVue Monitors with software revisions J.21.03,  J.21.19.    Model  Product  MP5  M8105A;  MP5SC  M8105AS;  MP5T   M8105AT;  MP5 Upgrade M8105AU ;  MP5SC Upgrade 866327    The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Philips Avalon Monitors with software revision J.30.58:    Model  Product  FM20  M2702A ;  FM30  M2703A ;  FM50  M2705A    Intended for: '' Monitoring the physiological parameters of pregnant women '' Non-invasive monitoring of fetal heart rates and movements.
Worldwide Distribution - USA (nationwide) including the states of  NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of  Korea, Singapore, Canada and Japan
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical  technique, the Persona Tibial Articular Inserter is used to seat the articular surface  implant onto the tibial baseplate.
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Nettle Leaf powder Gross Wt: 55.5 Lbs.  Net Wt: 55.0 Lbs.  This material is being sold for further processing, and for Manufacturing use only.  Distributed by Whole Herb Company
The product was tested and found to be positive for Salmonella.
US Distribution in states of: NY, VA, and MA.
Siemens Mammomat Inspiration mammography systems.    The Mammomat Inspiration system is intended for 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.
material #10140000, with serial numbers: 5018 3849  5042
The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already inserted, it could lead to an unintentional patient injury.
Plateletpheresis product, for which leukoreduction specifications were not met, was distributed.
US Distribution in states of:  FL and MA.
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308    Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.
McKesson Cardiology Hemo.   McKesson Cardiology'' Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes,  and to identify in a timely manner whether a parameter box is out of calibration.    McKesson has identified that its communication to customers regarding the  required maintenance tests was insufficient. While each unit has an attached  sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 HF4 and earlier versions of  the McKesson Cardiology Hemo user guides.
Outer Carton labeled in part as: Multiple Organics  Certified 100% Organic  Mango Fillets  Net Weight 20 Lbs. (9.07 kgs)  In 5 X 4 Lb. bags  Product of Mexico  Certified Organic by QAI  www.multipleorganics.com  USDA Organic    Inner plastic bag labeled in part as:  Organic Mango Filets  Net Weight 5Lbs (2.26 kgs)  Product of Mexico  Certified Organic by QAI  www.multipleorganics.com  209 Linus Pauling Dr., Hercules, CA 94547
Firm was notified that the product may contain fragments of metal that if ingested, may be injurious to human health. Firm has not been able to independently verify the reports, but believes it prudent to take this action.
Iowa, California, Colorado, Florida, Maryland, Massachusetts, New York, Ohio, Texas, Vermont, Virginia, Canada and Japan
next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901
Lot 460013; Best by: 2016.03.31 (on back label)
Next by Nature brand Dark Chocolate Cherries Lot 460013 may contain undeclared peanuts (from bulk product).
Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of the packaging. Sold to retail locations with 16 packages per case.
This voluntary recall has been initiated because the Kupiec Rice Cakes with Dark Chocolate may contain undeclared milk.
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20.   Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
Incorrect dimension on four liners was detected
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Symmetric Total Knee Femoral Components   Product Usage:  Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight:  20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC  27612
Products contain eggs which were recalled due to susceptibility to premature spoilage.
Golden Corral MEATLOAF MIX #18029, KEEP FROZEN, NET WEIGHT:  20 lbs (4 - 5 lb Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC  27612
Logan's Roadhouse Meatloaf Mix #25018, Keep Frozen, Net Weight:  40 Lbs. (20 - 2 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN  37921
PERKINS Meatloaf Mix #31607, Keep Frozen, Net Weight:  20.125 Lbs. (7 - 2.875 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN  37921
FLYING BISCUIT, Oatmeal Pancake Batter #70002, Keep Frozen, Net Weight:  20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN  37921
Ovation Brands Bead Pudding Base #67008, Keep Frozen, Net Weight:  20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN  37921
US Distribution including the states of  PA, NC, TN, NY, WI, WA and MI.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.    Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX .  Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.
Lot number 208140447  Batch Number 0060002;  Lot Number 208140458  Batch Number 0061723;  LotNumber208140487R Batch Number 0067938.
13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
Lotte International America Corp (LA Branch)
Nationwide in the US: California, Nevada, Arizona, New Mexico, Washington, Texas, Oklahoma, Illinois, New Jersey, Maryland, Georgia.   Worldwide to Canada retail stores.
Lotte International is recalling the Lotte Waffles because it contains undeclared eggs.
Worldwide Distribution: US (Nationwide) in the states of: AZ, AR, CA, DC, FL, ID, IL IN, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NJ, NY, NC, OK PA, SC, TN, TX, VA, and  WI; and internationally to: AUSTRALIA, BANGLADESH, CANADA, CHILE, CROATIA, EGYPT, GERMANY, ITALY, JORDAN, LEBANON, MALAYSIA, MOROCCO, OMAN, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, THAILAND, THE NETHERLANDS, UNITED KINGDOM.
Mortara Surveyor S12 and Surveyor S19 Patient Monitors.   Product Usage:  They are indicated for use in adult &#38; pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal &#38; inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the provided screws, it is then possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire.
Hapi Pudding, 3-pack, net wt. 8.46oz, UPC 11152 13417, JFC item #13417
Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
St Jude Medical, 10F Fast-Cath Trio'' Hemostasis Introducer, REF #  406308, Sterile EO.   The Fast-Cath Trio'' Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock''), dilator (10F) and 0.038 guidewire.  See product labeling for diagram of contents.
St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio'' Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015  Carton NDC #: 68084-149-01  Single Dose NDC #: 68084-149-11
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.