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Enforcement Report - Week of December 5, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Devices Event

Event ID	60030
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-11
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	First Medical Source LLC
City	Laguna Beach
State	CA
Country	US
Distribution Pattern	US Nationwide distribution in the state of IL

Associated Products

Product Description	Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Code Info	AccuFlux, Lot#: 91209.
Classification	Class I
Reason for Recall	Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ±15%.
Product Quantity	500 units
Recall Number	Z-0161-2013

Class I Drugs Event

Event ID	63017
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Samantha Lynn, Inc
City	Norwalk
State	CA
Country	US
Distribution Pattern	Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan

Associated Products

Product Description	Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Code Info	all lots within expiry through 2016
Classification	Class I
Reason for Recall	Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Product Quantity	25,888 Boxes
Recall Number	D-063-2013

Class I Food/Cosmetics Event

Event ID	63542
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	BumbleBar, Inc.
City	Spokane Valley
State	WA
Country	US
Distribution Pattern	Products are distributed nationwide and Hong Kong

Associated Products

Product Description	Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The product is labeled in parts: "*Cinnamon Sesame Bars With Flax Seeds & Roasted Peanutsgluten free cafe**NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
Code Info	Best By dates: 16APR13 BU1, 17APR13 BU1, 15MAR13 BU1, 22SEP12 BU1, 22AUG12 BU1, 23AUG12 BU1, 29JUN12 BU1, 24MAY12 BU1, 25APR12 BU1, and 02MAR12 BU1
Classification	Class I
Reason for Recall	Gluten Free Cafe Cinnamon Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product.
Product Quantity	1,323 case
Recall Number	F-0725-2013

Product Description	Gluten Free Cafe Chocolate Sesame Bar. The Retail Carton has a UPC 70795-03450 and the Individual Bar has a UPC 70795-03550. The product is labeled in parts: "*Chocolate Sesame Bars With Flax Seeds & Roasted Peanutsgluten free cafe**NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
Code Info	Best By dates: 01MAY13 BU1, 30APR13 BU1, 18MAR13 BU1, 20OCT12 BU1, 19OCT12 BU1, 17OCT12 BU1, 16OCT12 BU1, 04JUL12 BU1, 03JUL12 BU1, 26APR12 BU1, and 21MAR12 BU1.
Classification	Class I
Reason for Recall	Gluten Free Cafe Chocolate Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product.
Product Quantity	1,219 cases
Recall Number	F-0726-2013

Class I Food/Cosmetics Event

Event ID	63600
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Nov-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Wm Bolthouse Farms Inc
City	Bakersfield
State	CA
Country	US
Distribution Pattern	US and Canada

Associated Products

Product Description	Bolthouse Farms Carrot Chips (Croustilles Aux Carottes). No Preservatives. Product of the U.S.A. Net Wt. 16 oz (1 lb) 454 b poids net. UPC 71464 17209 Product was also packed under brand names of Safeway Farms, UPC 21130 70217 and Farm Stand (private label for SuperValue). Bolthouse Farms, Bakersfield, CA
Code Info	Bolthouse Farms Best if Used by NOV 12 2012 04 T xxxx BF212 J11 and Best If used by Nov 13, 2012 04T XXXX BF212 J12. Safeway Farms Best if Used by Nov 13, 2012 06 T xxx S2682 BF 212 J12 286. Farm Stand Best If Used by Nov 12-12-2012, 04 t xxxx BF 212 J11-12.
Classification	Class I
Reason for Recall	Random sampling conducted by the North Carolina Department of Agriculture and Consumer Protective Services had a positive result for Salmonella in Bolthouse Carrot Chips.
Product Quantity	5596 cases of 12 x 16 oz. per case.
Recall Number	F-0732-2013

Class I Food/Cosmetics Event

Event ID	63610
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	CSM Bakery Products NA
City	Tucker
State	GA
Country	US
Distribution Pattern	New York, New Jersey, Massachusetts, Illinois, Ohio, and Ontario, Canada

Associated Products

Product Description	Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged in # 10 cans, 3 cans per case.
Code Info	Lot # 1217800201; Expiration date 06/17/2014
Classification	Class I
Reason for Recall	The product contains undeclared allergens milk and soybean oil due to mislabeling.
Product Quantity	1973 cases
Recall Number	F-0731-2013

Class I Food/Cosmetics Event

Event ID	63666
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Nov-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Hillshire Brands Company
City	Downers Grove
State	IL
Country	US
Distribution Pattern	Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia

Associated Products

Product Description	Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen sandwich; 12 sandwiches per 2.74 lb case; UPC 54500 51434
Code Info	Incorrect back label: UPC 54500 51434, item 51434, code date 12292P1; Case SKU 51366
Classification	Class I
Reason for Recall	Some of the Jimmy Dean French Toast & Sausage Sandwiches were mislabeled on the back label with an ingredients statement for another product, resulting in undeclared allergens, egg and soy, not listed on the label.
Product Quantity	405 cases
Recall Number	F-0724-2013

Class I Food/Cosmetics Event

Event ID	63672
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Nestle USA
City	Glendale
State	CA
Country	US
Distribution Pattern	Nationwide in the US

Associated Products

Product Description	Nesquik Chocolate Powder, 1) 6x40.7oz, UPC 0 28000 68230 9. 2) 12x21.8oz, UPC 0 28000 68090 9. 3) 12x10.9oz, UPC 0 28000 67990 3.
Code Info	Production codes: 1) 2282574810 and 2282574820. 2)2278574810, 2278574820, 2279574810, 2279574820, 2284574820, 2284574830, 2285574810, 2285574820, 2287574820, 2289574810, 2289574820. 3) 2278574810.
Classification	Class I
Reason for Recall	Nestle is recalling Nesquik Chocolate Powder because certain lots of its ingredients, calcium carbonate, may be contaminated with Salmonella.
Product Quantity	18,768 units total
Recall Number	F-0737-2013

Class I Food/Cosmetics Event

Event ID	63673
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Kroger Co
City	Cincinnati
State	OH
Country	US
Distribution Pattern	Product was shipped to the following states: AZ, CO, ID, KS, MO, MT, NE, NM, NV,UT & WY.

Associated Products

Product Description	Kroger Deluxe French Vanilla Magnifique Ice Cream, 48 FL OZ laminated carton. INGREDIENTS: MILK, CREAM, SUGAR*CONTAINS: MILK, EGGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202*800-632-6900 or www.kroger.com.
Code Info	UPC 11110 50718; Sell By: Jun 12, 2013 49-70
Classification	Class I
Reason for Recall	The firm was notified that the ice cream may contain Pecans and, if eaten, could result in severe allergic reaction in persons sensitive to Pecans
Product Quantity	3112cs/6/48 fl oz cartons
Recall Number	F-0735-2013

Class I Food/Cosmetics Event

Event ID	63699
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
City	San Diego
State	CA
Country	US
Distribution Pattern	Nationwide in the US: TX, IL, UT, WA, CA, AZ.

Associated Products

Product Description	Chicken of the Sea Solid White Tuna in Water, 7 oz., 48 cans per case (case: 6 sets of multi-unit packs of 8 cans each), UPC 4800000097, case UPC 4800076127.
Code Info	Best By Date Can Code October 1 2016 BE11D ASWAP October 1 2016 BE11D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEAED ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEB2D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB4D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC4D ASWAP October 12 2016 BECAD ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC1D ASWAP October 12 2016 BEC5D ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE23D ASWAP October 2 2016 BE23D ASWAP October 2 2016 BE24D ASWAP October 2 2016 BE24D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2ED ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2ED ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE95D ASWAP October 9 2016 BE9AD ASWAP October 9 2016 BE9AD ASWAP October 9 2016 BE9BD ASWAP October 9 2016 BE9BD ASWAP October 9 2016 BE91D ASWAP October 9 2016 BE92D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE94D ASWAP October 9 2016 BE94D ASWAP October 9 2016 BE95D ASWAP
Classification	Class I
Reason for Recall	Chicken of the Sea is recalling Solid White Tuna in Water because the product label has undeclared soy allergen.
Product Quantity	42,168 cases
Recall Number	F-0736-2013

Class I Food/Cosmetics Event

Event ID	63720
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Ernimich, Inc. (dba Nina International, Inc.)
City	Hyattsville
State	MD
Country	US
Distribution Pattern	The products were sold in Virginia, Maryland and Washington, D.C.

Associated Products

Product Description	Ground Hot Pepper Chillies, 5 oz. plastic jars, 24 jars/case; jars labeled in part *Imported and distributed by Nina International Inc., P.O. Box 2176, Hyattsville, MD 20784Product of Ghana**
Code Info	UPC 745851004004
Classification	Class I
Reason for Recall	Food may be contaminated with Salmonella.
Product Quantity	36 cases
Recall Number	F-0734-2013

Class I Food/Cosmetics Event

Event ID	63727
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Whole Foods Market South Seafood Distribution
City	Roswell
State	GA
Country	US
Distribution Pattern	AL, GA, NC, SC and TN.

Associated Products

Product Description	Almondine Wedding Cookies sold by the pound.
Code Info	Purchased between 10/22/2012 and 11/15/2012
Classification	Class I
Reason for Recall	Product contains undeclared allergen: almonds .
Product Quantity	31 cases (320/5 oz cookies per case)
Recall Number	F-0738-2013

Product Description	Wedding Cookies (Baked Fresh In-Store), Whole Foods Market, sold by the pound.
Code Info	Purchased between 10/22/2012 and 11/15/2012
Classification	Class I
Reason for Recall	Product contains undeclared allergens: pecans.
Product Quantity
Recall Number	F-0739-2013

Class I Food/Cosmetics Event

Event ID	63749
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	United Dairy Farmers Inc
City	Norwood
State	OH
Country	US
Distribution Pattern	Ohio, Inidania, Kentucky, and Michigan

Associated Products

Product Description	United Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square
Code Info	B23111 B23712
Classification	Class I
Reason for Recall	Product may contain salmonella
Product Quantity	1150 (3 gallon) units
Recall Number	F-0740-2013

Class II Biologics Event

Event ID	39103
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Apr-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Illinois

Associated Products

Product Description	Red Blood Cells
Code Info	C85832
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity	1 Unit
Recall Number	B-0085-13

Class II Biologics Event

Event ID	39114
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Illinois; Iowa; Switzerland

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	LR07481
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity	1 Unit
Recall Number	B-0086-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	LR06314
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity	1 Unit
Recall Number	B-0087-13

Class II Biologics Event

Event ID	47971
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Mar-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Ogden
State	UT
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	07OUTE7481; 07OUTE6595; 07OUTE5995; 07OUTE5440; 07OUTE3268; 07OUTE2865; 07OUTE1483; 07OUTE1041; 07OUTD9210; 07OUTD8745; 07OUTD8184; 07OUTD7577; 07OUTD6988; 07OUTD6075; 07OUTD5854; 07OUTD0584; 07OUTC7070; 07OUTC6440; 07OUTC1645; 07OUTC2199; 07OUTC3461; 07OUTC3772; 07OUTC4978; 07OUTC5334; 07OUTC5999
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity	25 units
Recall Number	B-0088-13

Class II Biologics Event

Event ID	49304
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jun-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	BioLife Plasma Services L.P.
City	Independence
State	MO
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	07IMOD8365; 07IMOD8086; 07IMOD9626; 08IMOC2350; 08IMOC1236; 08IMOC0517; 08IMOB9411; 08IMOA7165; 07IMOF2982; 07IMOF1494; 07IMOE8541; 07IMOE8131; 07IMOE7029; 07IMOE5551; 07IMOE4790; 07IMOE2580; 07IMOE1607; 07IMOD9837; 07IMOD2723; 07IMOD3620; 07IMOD4070; 07IMOD5186; 07IMOD5575; 07IMOD6637; 07IMOD6938
Classification	Class II
Reason for Recall	Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity	25 units
Recall Number	B-0090-13

Class II Biologics Event

Event ID	55396
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jan-10
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc.
City	Lawrence
State	KS
Country	US
Distribution Pattern	Illinois; Germany; Switzerland

Associated Products

Product Description	Source Plasma
Code Info	0120670922; 0120670420; 0120669623; 0120669233; 0120668631; 0120666057; 0120664300; 0120663873; 0120662673; 0120661633; 0120660951; 0120660581; 0120660044; 0120659556; 0120658867; 0120658422; 0120657338; 0120657046; 0120656310; 0120655992; 0120651739; 0120651008; 0120650195; 0120649474; 0120648612; 0120648062; 0120647087; 0120646615; 0120645595; 0120645206; 0120644218; 0120643550; 0120637632; 0120635366; 0120634217; 0120633574; 0120632409; 0120631978; 0120630408; 0120629596; 0120628386; 0120627877; 0120626800; 0120626336; 0120624193; 0120623705; 0120622656; 0120622229; 0120621101; 0120620702; 0120619738; 0120619204; 0120618173; 0120617647; 0120616569; 0120615589; 0120614950; 0120614086; 0120613388; 0120611482; 0120611242.
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	61 Units
Recall Number	B-0092-13

Class II Biologics Event

Event ID	55397
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jan-10
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc.
City	Kansas City
State	MO
Country	US
Distribution Pattern	Illinois; North Carolina; Germany; Switzerland

Associated Products

Product Description	Source Plasma
Code Info	0111149111; 0111147834; 0111146858; 0111145398; 0111144544; 0111140295; 0111139418; 0111137586; 0111136853; 0111135164; 0111132473; 0111110562; 0111108783; 0111108007; 0111105480; 0111104143; 0111103129; 0111101609; 0111100446; 0111098621; 0111097833; 0111096140; 0111094912; 0111093305; 0111092212; 0111090898; 0111089695; 0111086002; 0111084770; 0111083520; 0111082406; 0111081158; 0111079979; 0111078736; 8750013927; 8750012649; 8750011299; 8750009785; 8750008278; 8750007210; 8750005857; 8750003894; 8750000361; 0111072791; 0111070491; 0111069856; 0111066340; 0111065204; 0111062461; 0111061817; 0111057970; 0111056553; 0111053550; 0111052886.
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed
Product Quantity	54 Units
Recall Number	B-0093-13

Class II Food/Cosmetics Event

Event ID	60965
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Oct-11
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Quality Dairy Farms Inc.
City	Boonville
State	NY
Country	US
Distribution Pattern	Upstate New York

Associated Products

Product Description	Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231
Code Info	1243, 1236, 1208, 1224, 1203, 1214
Classification	Class II
Reason for Recall	The ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity	454 half gallon units
Recall Number	F-0727-2013

Product Description	Mercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392
Code Info	1243, 1236, 1208, 1224, 1203, 1214
Classification	Class II
Reason for Recall	The ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity	499 half gallon units
Recall Number	F-0728-2013

Product Description	Mercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513
Code Info	1243, 1236, 1208, 1224, 1203, 1214
Classification	Class II
Reason for Recall	The ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity	241 half gallon units
Recall Number	F-0729-2013

Class II Devices Event

Event ID	62918
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Apr-11
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Extremity Medical LLC
City	Parsippany
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.

Associated Products

Product Description	IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Code Info	Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
Classification	Class II
Reason for Recall	Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Product Quantity	156 units
Recall Number	Z-0438-2013

Class II Biologics Event

Event ID	62954
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BloodSource, Inc.
City	Mather
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W035812021588; W035812021588; W035811150375; W035811074394; W035811060067; W035810379496; W035810403681;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	7 units
Recall Number	B-0005-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W035812006969; W035811150375; W035811074394; W035811074394; W035811060067; W035810379496; W035810403681;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	7 units
Recall Number	B-0006-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W035812006758; W035810322840; W035810321291; W035809206091; W035809227265; W035809124885;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	6 units
Recall Number	B-0008-13

Class II Biologics Event

Event ID	62973
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112219699*;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-0002-13

Class II Biologics Event

Event ID	62975
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc
City	Huntsville
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W1151122175155;
Classification	Class II
Reason for Recall	Blood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-0003-13

Class II Biologics Event

Event ID	63012
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	New York Blood Center, Inc.
City	Westbury
State	NY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W0470121985440 (Part A); W0470121985440(Part B)
Classification	Class II
Reason for Recall	Blood products, for which quality control and distribution of products did not meet specifications, were distributed.
Product Quantity	2 units
Recall Number	B-0035-13

Class II Biologics Event

Event ID	63013
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	Pennsylvania; Colorado

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036212407825;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed.
Product Quantity	1 unit
Recall Number	B-0045-13

Product Description	Plasma Frozen within 24 hours (FP24)
Code Info	W036212402329;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed.
Product Quantity	1 unit
Recall Number	B-0046-13

Class II Biologics Event

Event ID	63037
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Lake Worth
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W036810136115(Part A); W036810136115(Part B)
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-0039-13

Class II Biologics Event

Event ID	63038
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Lake Worth
State	FL
Country	US
Distribution Pattern	Florida; New York

Associated Products

Product Description	Red Blood Cells
Code Info	8486241;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0036-13

Product Description	Fresh Frozen Plasma
Code Info	8486241;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0037-13

Class II Biologics Event

Event ID	63039
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Michigan Blood
City	Grand Rapids
State	MI
Country	US
Distribution Pattern	Michigan

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W120612090715;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-0038-13

Class II Devices Event

Event ID	63212
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE Healthcare, LLC
City	Waukesha
State	WI
Country	US
Distribution Pattern	Nationwide distribution

Associated Products

Product Description	GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Code Info	Model No - 5555000-5
Classification	Class II
Reason for Recall	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Product Quantity	217 total Installed in the US
Recall Number	Z-0448-2013

Product Description	GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Code Info	Model No - 5555000-6
Classification	Class II
Reason for Recall	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Product Quantity	217 total Installed in the US
Recall Number	Z-0449-2013

Product Description	GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Code Info	Model No - 5421698
Classification	Class II
Reason for Recall	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Product Quantity	217 total installed in the US
Recall Number	Z-0450-2013

Class II Devices Event

Event ID	63235
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Parks Medical Electronics, Inc
City	Aloha
State	OR
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela.

Associated Products

Product Description	Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include 2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, 1059-C, 1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. ( = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
Code Info	Domestic Distribution: 013053, 013104, 013107, 013124, 013154, 013182, 013193, 014203, 014237, 014248, 014249, 014252, 014253, 014254, 014269, 014276, 014310, 014335, 014339, 014361, 014366, 014376, 014380, 014381, 014382, 014384, 014397, 014401, 014406, 014416, 014424, 014429, 014431, 014443, 014444, 014448, 014454, 014458, 014530, 014532, 014533, 014540, 014542, 014545, 014547, 014551, 014552, 014552, 014553, 014598, 014601, 014604, 014608, 014616, 014654, 014657, 014659, 014660, 014661, 014663, 103077, 105X-600001024, 105X-600001025, 105X-600001026, 105X-600001027, 105X-800001019, 105X-800001022, 105X-800001023, 105X-800001024, 105X-800001026, 105X-800001027, 105X-800001027, 105X-800001028, 105X-800001029, 105X-800001030, 105X-800001031, 105X-E00001001, 105X-E00001002, 105X-E00001003, 105X-E00001004, 105X-E00001005, 105X-E00001007, 105X-E00001008, 105X-E00001009, 105X-E00001010, 105X-E00001011, 105X-E00001012, 105X-E00001013, 105X-E00001014, 105X-E00001016, 105X-E00001017, 105X-E00001018, 105X-E00001019, 105X-E00001020, 105X-F00001000, 105X-F00001001, 105X-F00001002, 105X-F00001003, 105X-F00001004, 105X-F00001005, 105X-F00001005, 105X-F00001006, 105X-F00001007, 105X-F00001008, 105X-F00001009, 105X-F00001010, 105X-F00001011, 105X-F00001012, 105X-F00001013, 105X-F00001014, 105X-F00001015, 105X-F00001016, 105X-F00001017, 105X-F00001018, 105X-F00001020, 105X-F00001021, 105X-F00001022, 105X-F00001023. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Foreign distribution: 01301, 013043, 013044, 013045, 013046, 013072, 013076, 013175, 013181, 013183, 013188, 014215, 014386, 014392, 014393, 014456, 014535, 014550, 014551, 014561, 014562, 014563, 105X-800001025, 105X-922001017, 105X-922001018, 105X-922001019, 105X-922001021, 105X-9221020, 105X-923001001, 105X-923001002, 105X-923001003, 105X-923001004, 105X-923001005, 105X-923001006, 105X-923001007, 105X-923001007, 105X-923001009, 105X-923001010, 105X-923001011, 105X-E00001000, 105X-E00001003, 105X-E00001006, 105X-E00001015, 105X-F00001019. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify.
Classification	Class II
Reason for Recall	Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.
Product Quantity	349 units (Domestic: 270 units - Foreign: 79 units)
Recall Number	Z-0443-2013

Class II Devices Event

Event ID	63410
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Diamedix Corporation
City	Miami
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador

Associated Products

Product Description	The Is-anti-Sm test kits**Catalog No: 720-240* Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Code Info	Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Classification	Class II
Reason for Recall	Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Product Quantity	65 Test Kits
Recall Number	Z-0445-2013

Class II Food/Cosmetics Event

Event ID	63498
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Nestle Professional
City	Tampa
State	FL
Country	US
Distribution Pattern	Distributed to CA.

Associated Products

Product Description	Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case.
Code Info	UPC code on the 50 count box: 50000-351107. A production code on the 50 count box: 214651186 with a time stamp from 2:30 to 3:34. Best buy date on 50 count box: Mar 2013
Classification	Class II
Reason for Recall	Nestle Professional Vitality initiated a recall on 10/9/12 of their Nestle COFFEE-MATE Original Liquid Creamer Singles due to a manufacturing error that causes the creamer to become acidic.
Product Quantity	520 cases
Recall Number	F-0733-2013

Class II Food/Cosmetics Event

Event ID	63523
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Gasco Industrial
City	Gurabo
State	PR
Country	US
Distribution Pattern	PR only

Associated Products

Product Description	"Sazon con Culantro y Achiote" (seasoning)
Code Info	100917, 100920, 101110, 101201, 110120, 110503, 110624, 110802, 120224, 120330, 120612, 120821, 120924
Classification	Class II
Reason for Recall	Undeclared colors: FD&C Yellow #5, Yellow#6 and Red #40
Product Quantity	1221 cases
Recall Number	F-0730-2013

Class II Devices Event

Event ID	63543
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.

Associated Products

Product Description	100/120V AC, Advanced Perfusion System Platform (APS) The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Info	Catalog number: 801763 and all serial numbers
Classification	Class II
Reason for Recall	Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limited in the ability to provide adequate cardiopulmonary support. The potential injury is high should this apparently rare event occur and the event with recovery steps is not described in the operator manual.
Product Quantity	1647 units total
Recall Number	Z-0435-2013

Product Description	220/240V AC, Advanced Perfusion System Platform (APS) The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Info	Catalog number: 801764 and all serial numbers
Classification	Class II
Reason for Recall	Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limited in the ability to provide adequate cardiopulmonary support. The potential injury is high should this apparently rare event occur and the event with recovery steps is not described in the operator manual.
Product Quantity	1647 units total
Recall Number	Z-0436-2013

Class II Devices Event

Event ID	63544
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Zimmer, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,

Associated Products

Product Description	NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGenÂ® system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Code Info	Catalog 00-5986-047-02, lots 62049114 and 62045235.
Classification	Class II
Reason for Recall	Zimmer is initiating a lot specific recall of the NexGen® Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset allergic reaction and accelerated polyethylene wear caused by third body particles.
Product Quantity	123 worldwide (33 USA)
Recall Number	Z-0437-2013

Class II Devices Event

Event ID	63583
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Metrex Research, LLC.
City	Romulus
State	MI
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.

Associated Products

Product Description	Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Code Info	Part Number Lot Number 4511 201008270110
Classification	Class II
Reason for Recall	The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Product Quantity	3,348 units
Recall Number	Z-0444-2013

Class II Drugs Event

Event ID	63630
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Boehringer Ingelheim Roxane Inc
City	Columbus
State	OH
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Code Info	Lot 201900 Expiration Date: JAN 2015
Classification	Class II
Reason for Recall	Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Product Quantity	8,381 bottles
Recall Number	D-067-2013

Class II Devices Event

Event ID	63649
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Sep-10
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Kimberly-Clark Corporation
City	Roswell
State	GA
Country	US
Distribution Pattern	Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI

Associated Products

Product Description	Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Code Info	Serial Number - SA09043017, SA09043019, SA0904320, SA09043018, SA09043015, SA09043012, SA09043016, SA09043014, SA09043013, SA09043009, SA09043011, SA09043010, SA09043008, SA09043007, SA09043006, SA09043003, SA09043005, SA09043004, SA09043002, SA09043001, SA09020013, SA09020012, SA09020014, SA09020011, SA09020010, SA09020009, SA0902008, SA09020006, SA09020007, SA08343100, SA09020004, SA09020005, SA09020002, SA09020003, SA09020001, SA08343099, SA08343098, SA08343097, SA08343096, SA08343095, SA08343094, SA08343093, SA08343092, SA08343091, SA08343090, SA08343089, SA08343087, SA08343088, SA08343086, SA08343085, SA08343083, SA08343084, SA08343053, SA08343073, SA08288014, SA08288002, SA08343054, SA08343082, SA08343081, SA08343080, SA08343079, SA08343078, SA08343077, SA08165007, SA08343076, SA08343075, SA08343074, SA08343072, SA08343055, SA08288007, SA08343071, SA08343070, SA08343069, SA08343068, SA08343067, SA08343066, SA08343065, SA08343064, SA08343063, SA08343059, SA08343058, SA08343062, SA08343061, SA08343060, SA08343056, SA08343057, SA08288012, SA08288017, SA08288016, SA08288015, SA08288013, SA08288011, SA08288009, SA08288006, SA08288003, SA08288010, SA08288008, SA08288004, SA08288005, SA08288001, SA08165013, SA08165014, SA08165015, SA08165018, SA08165016, SA08165017, SA08165006, SA08165005, SA08165011, SA08165012, SA08165010, SA08165009, SA08165004, SA08165008, SA08165002, SA08165003, SA08144035, SA08144030, SA08165001, SA08144034, SA08144033, SA08144032, SA08144031, SA08144029, SA08144028, SA08144025, SA08144027, SA08144021, SA08144026, SA08144024, SA08144023, SA08144022, SA08136010, SA08136006, SA08136003, SA08136009, SA08136005, SA08136004, SA08136007, SA08136001, SA08136002, SA08136008, SA08094129, SA08094137, SA08094141, SA08094136, SA08094150, SA08094153, SA08094152, SA08094151, SA08094149, SA08094145, SA08094148, SA08094147, SA08094143, SA08094146, SA08094142, SA08094144, SA08094140, SA08094139, SA08094138, SA08094134, SA08094130, SA08094132, SA08094135, SA08094131, SA08094133, SA08094127, SA08094128, SA08094125, SA08094126, SA08094124, SA08017044, SA08017049, SA08017045, SA08017040, SA08017034, SA08017035, SA08017041, SA08017047, SA08017042, SA08017043, SA08017048, SA08017039, SA08017046, SA08017038, SA08017037, SA08017030, SA08017036, SA08017028, SA08017029, SA08017027, SA08017033, SA08017031, SA08017032, SA07344022, SA07344029, SA07344028, SA07344026, SA07344027, SA07344030, SA07344021, SA07344023, SA07344024, SA07344025, SA07320002, SA07320001, SA07320014, SA07320015, SA07320013, SA07320011, SA07320012, SA07320006, SA07320005, SA07320008, SA07320010, SA07320009, SA07320007, SA07320004, SA07320003, SA07261006, SA07257008, SA07261004, SA07261007, SA07261002, SA07257004, SA07257007, SA07257003, SA07257002, SA07261005, SA07261008, SA07261003, SA07261001, SA07257005, SA07257006, SA07257001, SA07250005, SA07250004, SA07250002, SA07250003, SA07250001, SA07228007, SA07228008, SA07228001, SA07228002, SA07228003, SA07228004, SA07228005, SA07228006, SA07180006, SA07180005, SA07180004, SA07180003, SA07180002, SA07180001, SC07171006, SC07171005, SC07171004, SC07171003, SC07171002, SC07171001
Classification	Class II
Reason for Recall	Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Product Quantity	400 units
Recall Number	Z-0451-2013

Class II Drugs Event

Event ID	63661
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Procter & Gamble Co
City	Mason
State	OH
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
Code Info	Lot #2278171941, Exp. 09/14, Lot #2282171981, Exp. 09/14 .
Classification	Class II
Reason for Recall	Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Product Quantity	17,532 bottles
Recall Number	D-069-2013

Class II Devices Event

Event ID	63675
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Iradimed Corporation
City	Winter Park
State	FL
Country	US
Distribution Pattern	Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.

Associated Products

Product Description	The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
Code Info	The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month.
Classification	Class II
Reason for Recall	Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.
Product Quantity	719 sets
Recall Number	Z-0446-2013

Class II Devices Event

Event ID	63681
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Cooper Surgical, Inc.
City	Trumbull
State	CT
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.

Associated Products

Product Description	Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Code Info	All serial numbers
Classification	Class II
Reason for Recall	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Product Quantity	1215 total
Recall Number	Z-0439-2013

Product Description	Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Code Info	Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
Classification	Class II
Reason for Recall	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Product Quantity	1215 total
Recall Number	Z-0440-2013

Class II Drugs Event

Event ID	63691
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GlaxoSmithKline, LLC.
City	Zebulon
State	NC
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
Code Info	Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Classification	Class II
Reason for Recall	Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Product Quantity	1,319 vials
Recall Number	D-068-2013

Class II Devices Event

Event ID	63711
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomet, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: AZ, MD, and KS.

Associated Products

Product Description	Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
Code Info	Catalog Number: 192411 and Lot Number Identification: 244800
Classification	Class II
Reason for Recall	It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Product Quantity	4
Recall Number	Z-0442-2013

Class II Devices Event

Event ID	63722
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Medtronic Navigation, Inc.
City	Louisville
State	CO
Country	US
Distribution Pattern	Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.

Associated Products

Product Description	The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .
Code Info	Lot number 120203.
Classification	Class II
Reason for Recall	Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
Product Quantity	12 Units
Recall Number	Z-0441-2013

Class II Drugs Event

Event ID	63759
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ranbaxy Inc.
City	Princeton
State	NJ
Country	US
Distribution Pattern	Nationwide and PR

Associated Products

Product Description	Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90
Code Info	Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Classification	Class II
Reason for Recall	Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity	120,201 Bottles
Recall Number	D-070-2013

Product Description	Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90
Code Info	Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.
Classification	Class II
Reason for Recall	Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity	203,198 Bottles
Recall Number	D-071-2013

Product Description	Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.
Code Info	a) 40 mg 90 count, Lot #s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count, Lot #s: 2437956, 2437957, 2440675, Exp 08/31/2014.
Classification	Class II
Reason for Recall	Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity	157,026 Bottles
Recall Number	D-072-2013

Class III Biologics Event

Event ID	48247
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Ogden
State	UT
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	07OUTF1661; 07OUTF2092; 07OUTF3219; 08OUTF2071; 08OUTF4413; 08OUTF5051; 08OUTF5772; 08OUTF6290; 08OUTF6931; 07OUTF4170; 07OUTF4787; 2473; 08OUTF7761; 08OUTF8282
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity	14 units
Recall Number	B-0089-13

Class III Biologics Event

Event ID	62937
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Florida Blood Services, Inc.
City	Pensacola
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells Washed
Code Info	W11631271022400;
Classification	Class III
Reason for Recall	Blood product, which was washed with an incorrect wash solution, was distributed.
Product Quantity	1 unit
Recall Number	B-0004-13

Class III Biologics Event

Event ID	62959
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeShare Blood Centers
City	Alexandria
State	LA
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036512069578;
Classification	Class III
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-0001-13

Class III Drugs Event

Event ID	63707
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GlaxoSmithKline, LLC.
City	Zebulon
State	NC
Country	US
Distribution Pattern	Nationwide and Puerto Rico.

Associated Products

Product Description	Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
Code Info	Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13.
Classification	Class III
Reason for Recall	Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Quantity	310,964 Aerosol Units
Recall Number	D-064-2013

Product Description	Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
Code Info	1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Classification	Class III
Reason for Recall	Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Quantity	18,676 Aerosol Units
Recall Number	D-065-2013

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