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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Class I Devices Event

Event ID60030
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFirst Medical Source LLC
CityLaguna Beach
StateCA
CountryUS
Distribution PatternUS Nationwide distribution in the state of IL
 

Associated Products

Product DescriptionMedpro 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 InfoAccuFlux, Lot#: 91209.
ClassificationClass I
Reason for RecallPlease 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 Quantity500 units
Recall NumberZ-0161-2013

Class I Drugs Event

Event ID63017
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSamantha Lynn, Inc
CityNorwalk
StateCA
CountryUS
Distribution PatternNationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
 

Associated Products

Product DescriptionReumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Code Infoall lots within expiry through 2016
ClassificationClass I
Reason for RecallMarketed 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 Quantity25,888 Boxes
Recall NumberD-063-2013

Class I Food Event

Event ID63542
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBumbleBar, Inc.
CitySpokane Valley
StateWA
CountryUS
Distribution PatternProducts are distributed nationwide and Hong Kong
 

Associated Products

Product DescriptionGluten 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 Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
Code InfoBest By dates: 16APR13 BU1, 17APR13 BU1, 15MAR13 BU1, 22SEP12 BU1, 22AUG12 BU1, 23AUG12 BU1, 29JUN12 BU1, 24MAY12 BU1, 25APR12 BU1, and 02MAR12 BU1
ClassificationClass I
Reason for RecallGluten 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 Quantity1,323 case
Recall NumberF-0725-2013
Product DescriptionGluten 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 Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
Code InfoBest 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.
ClassificationClass I
Reason for RecallGluten 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 Quantity1,219 cases
Recall NumberF-0726-2013

Class I Food Event

Event ID63600
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmWm Bolthouse Farms Inc
CityBakersfield
StateCA
CountryUS
Distribution PatternUS and Canada
 

Associated Products

Product DescriptionBolthouse 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 InfoBolthouse 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.
ClassificationClass I
Reason for RecallRandom sampling conducted by the North Carolina Department of Agriculture and Consumer Protective Services had a positive result for Salmonella in Bolthouse Carrot Chips.
Product Quantity5596 cases of 12 x 16 oz. per case.
Recall NumberF-0732-2013

Class I Food Event

Event ID63610
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCSM Bakery Products NA
CityTucker
StateGA
CountryUS
Distribution PatternNew York, New Jersey, Massachusetts, Illinois, Ohio, and Ontario, Canada
 

Associated Products

Product DescriptionMurray'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 InfoLot # 1217800201; Expiration date 06/17/2014
ClassificationClass I
Reason for RecallThe product contains undeclared allergens milk and soybean oil due to mislabeling.
Product Quantity1973 cases
Recall NumberF-0731-2013

Class I Food Event

Event ID63666
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHillshire Brands Company
CityDowners Grove
StateIL
CountryUS
Distribution PatternIowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia
 

Associated Products

Product DescriptionJimmy 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 InfoIncorrect back label: UPC 54500 51434, item 51434, code date 12292P1; Case SKU 51366
ClassificationClass I
Reason for RecallSome 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 Quantity405 cases
Recall NumberF-0724-2013

Class I Food Event

Event ID63672
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmNestle USA
CityGlendale
StateCA
CountryUS
Distribution PatternNationwide in the US
 

Associated Products

Product DescriptionNesquik 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 InfoProduction codes: 1) 2282574810 and 2282574820. 2)2278574810, 2278574820, 2279574810, 2279574820, 2284574820, 2284574830, 2285574810, 2285574820, 2287574820, 2289574810, 2289574820. 3) 2278574810.
ClassificationClass I
Reason for RecallNestle is recalling Nesquik Chocolate Powder because certain lots of its ingredients, calcium carbonate, may be contaminated with Salmonella.
Product Quantity18,768 units total
Recall NumberF-0737-2013

Class I Food Event

Event ID63673
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKroger Co
CityCincinnati
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AZ, CO, ID, KS, MO, MT, NE, NM, NV,UT & WY.
 

Associated Products

Product DescriptionKroger 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 InfoUPC 11110 50718; Sell By: Jun 12, 2013 49-70
ClassificationClass I
Reason for RecallThe 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 Quantity3112cs/6/48 fl oz cartons
Recall NumberF-0735-2013

Class I Food Event

Event ID63699
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTri-Union Seafoods, L.L.C dba Chicken of the Sea.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide in the US: TX, IL, UT, WA, CA, AZ.
 

Associated Products

Product DescriptionChicken 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 InfoBest 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
ClassificationClass I
Reason for RecallChicken of the Sea is recalling Solid White Tuna in Water because the product label has undeclared soy allergen.
Product Quantity42,168 cases
Recall NumberF-0736-2013

Class I Food Event

Event ID63720
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmErnimich, Inc. (dba Nina International, Inc.)
CityHyattsville
StateMD
CountryUS
Distribution PatternThe products were sold in Virginia, Maryland and Washington, D.C.
 

Associated Products

Product DescriptionGround 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 20784***Product of Ghana***
Code InfoUPC 745851004004
ClassificationClass I
Reason for RecallFood may be contaminated with Salmonella.
Product Quantity36 cases
Recall NumberF-0734-2013

Class I Food Event

Event ID63727
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market South Seafood Distribution
CityRoswell
StateGA
CountryUS
Distribution PatternAL, GA, NC, SC and TN.
 

Associated Products

Product DescriptionAlmondine Wedding Cookies sold by the pound.
Code InfoPurchased between 10/22/2012 and 11/15/2012
ClassificationClass I
Reason for RecallProduct contains undeclared allergen: almonds .
Product Quantity31 cases (320/5 oz cookies per case)
Recall NumberF-0738-2013
Product DescriptionWedding Cookies (Baked Fresh In-Store), Whole Foods Market, sold by the pound.
Code InfoPurchased between 10/22/2012 and 11/15/2012
ClassificationClass I
Reason for RecallProduct contains undeclared allergens: pecans.
Product Quantity
Recall NumberF-0739-2013

Class I Food Event

Event ID63749
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUnited Dairy Farmers Inc
CityNorwood
StateOH
CountryUS
Distribution PatternOhio, Inidania, Kentucky, and Michigan
 

Associated Products

Product DescriptionUnited Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square
Code InfoB23111 B23712
ClassificationClass I
Reason for RecallProduct may contain salmonella
Product Quantity1150 (3 gallon) units
Recall NumberF-0740-2013

Class II Biologics Event

Event ID39103
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoC85832
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity1 Unit
Recall NumberB-0085-13

Class II Biologics Event

Event ID39114
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIllinois; Iowa; Switzerland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLR07481
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity1 Unit
Recall NumberB-0086-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoLR06314
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity1 Unit
Recall NumberB-0087-13

Class II Biologics Event

Event ID47971
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07OUTE7481; 07OUTE6595; 07OUTE5995; 07OUTE5440; 07OUTE3268; 07OUTE2865; 07OUTE1483; 07OUTE1041; 07OUTD9210; 07OUTD8745; 07OUTD8184; 07OUTD7577; 07OUTD6988; 07OUTD6075; 07OUTD5854; 07OUTD0584; 07OUTC7070; 07OUTC6440; 07OUTC1645; 07OUTC2199; 07OUTC3461; 07OUTC3772; 07OUTC4978; 07OUTC5334; 07OUTC5999
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity25 units
Recall NumberB-0088-13

Class II Biologics Event

Event ID49304
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBioLife Plasma Services L.P.
CityIndependence
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07IMOD8365; 07IMOD8086; 07IMOD9626; 08IMOC2350; 08IMOC1236; 08IMOC0517; 08IMOB9411; 08IMOA7165; 07IMOF2982; 07IMOF1494; 07IMOE8541; 07IMOE8131; 07IMOE7029; 07IMOE5551; 07IMOE4790; 07IMOE2580; 07IMOE1607; 07IMOD9837; 07IMOD2723; 07IMOD3620; 07IMOD4070; 07IMOD5186; 07IMOD5575; 07IMOD6637; 07IMOD6938
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity25 units
Recall NumberB-0090-13

Class II Biologics Event

Event ID55396
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jan-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityLawrence
StateKS
CountryUS
Distribution PatternIllinois; Germany; Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info0120670922; 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.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity61 Units
Recall NumberB-0092-13

Class II Biologics Event

Event ID55397
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jan-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityKansas City
StateMO
CountryUS
Distribution PatternIllinois; North Carolina; Germany; Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info0111149111; 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.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed
Product Quantity54 Units
Recall NumberB-0093-13

Class II Food Event

Event ID60965
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Oct-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmQuality Dairy Farms Inc.
CityBoonville
StateNY
CountryUS
Distribution PatternUpstate New York
 

Associated Products

Product DescriptionMercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231
Code Info1243, 1236, 1208, 1224, 1203, 1214
ClassificationClass II
Reason for RecallThe ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity454 half gallon units
Recall NumberF-0727-2013
Product DescriptionMercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392
Code Info1243, 1236, 1208, 1224, 1203, 1214
ClassificationClass II
Reason for RecallThe ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity499 half gallon units
Recall NumberF-0728-2013
Product DescriptionMercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513
Code Info1243, 1236, 1208, 1224, 1203, 1214
ClassificationClass II
Reason for RecallThe ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Quantity241 half gallon units
Recall NumberF-0729-2013

Class II Devices Event

Event ID62918
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmExtremity Medical LLC
CityParsippany
StateNJ
CountryUS
Distribution PatternWorldwide 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 DescriptionIO 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 InfoProduct coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
ClassificationClass II
Reason for RecallProduct Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Product Quantity156 units
Recall NumberZ-0438-2013

Class II Biologics Event

Event ID62954
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodSource, Inc.
CityMather
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW035812021588; W035812021588; W035811150375; W035811074394; W035811060067; W035810379496; W035810403681;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity7 units
Recall NumberB-0005-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW035812006969; W035811150375; W035811074394; W035811074394; W035811060067; W035810379496; W035810403681;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity7 units
Recall NumberB-0006-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035812006758; W035810322840; W035810321291; W035809206091; W035809227265; W035809124885;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity6 units
Recall NumberB-0008-13

Class II Biologics Event

Event ID62973
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112219699*;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0002-13

Class II Biologics Event

Event ID62975
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc
CityHuntsville
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151122175155;
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0003-13

Class II Biologics Event

Event ID63012
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNew York Blood Center, Inc.
CityWestbury
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW0470121985440 (Part A); W0470121985440(Part B)
ClassificationClass II
Reason for RecallBlood products, for which quality control and distribution of products did not meet specifications, were distributed.
Product Quantity2 units
Recall NumberB-0035-13

Class II Biologics Event

Event ID63013
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternPennsylvania; Colorado
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036212407825;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed.
Product Quantity1 unit
Recall NumberB-0045-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW036212402329;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed.
Product Quantity1 unit
Recall NumberB-0046-13

Class II Biologics Event

Event ID63037
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW036810136115(Part A); W036810136115(Part B)
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0039-13

Class II Biologics Event

Event ID63038
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida; New York
 

Associated Products

Product DescriptionRed Blood Cells
Code Info8486241;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0036-13
Product DescriptionFresh Frozen Plasma
Code Info8486241;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0037-13

Class II Biologics Event

Event ID63039
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMichigan Blood
CityGrand Rapids
StateMI
CountryUS
Distribution PatternMichigan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW120612090715;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-0038-13

Class II Devices Event

Event ID63212
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternNationwide distribution
 

Associated Products

Product DescriptionGE 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 InfoModel No - 5555000-5
ClassificationClass II
Reason for RecallGE 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 Quantity217 total Installed in the US
Recall NumberZ-0448-2013
Product DescriptionGE 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 InfoModel No - 5555000-6
ClassificationClass II
Reason for RecallGE 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 Quantity217 total Installed in the US
Recall NumberZ-0449-2013
Product DescriptionGE 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 InfoModel No - 5421698
ClassificationClass II
Reason for RecallGE 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 Quantity217 total installed in the US
Recall NumberZ-0450-2013

Class II Devices Event

Event ID63235
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmParks Medical Electronics, Inc
CityAloha
StateOR
CountryUS
Distribution PatternWorldwide 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 DescriptionDevices 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 InfoDomestic 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.
ClassificationClass II
Reason for RecallParks 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 Quantity349 units (Domestic: 270 units - Foreign: 79 units)
Recall NumberZ-0443-2013

Class II Devices Event

Event ID63410
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDiamedix Corporation
CityMiami
StateFL
CountryUS
Distribution PatternWorldwide 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 DescriptionThe 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 InfoCatalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
ClassificationClass II
Reason for RecallDiamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Product Quantity65 Test Kits
Recall NumberZ-0445-2013

Class II Food Event

Event ID63498
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNestle Professional
CityTampa
StateFL
CountryUS
Distribution PatternDistributed to CA.
 

Associated Products

Product DescriptionNestle 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 InfoUPC 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
ClassificationClass II
Reason for RecallNestle 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 Quantity520 cases
Recall NumberF-0733-2013

Class II Food Event

Event ID63523
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGasco Industrial
CityGurabo
StatePR
CountryUS
Distribution PatternPR only
 

Associated Products

Product Description"Sazon con Culantro y Achiote" (seasoning)
Code Info100917, 100920, 101110, 101201, 110120, 110503, 110624, 110802, 120224, 120330, 120612, 120821, 120924
ClassificationClass II
Reason for RecallUndeclared colors: FD&C Yellow #5, Yellow#6 and Red #40
Product Quantity1221 cases
Recall NumberF-0730-2013

Class II Devices Event

Event ID63543
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide 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 Description100/120V 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 InfoCatalog number: 801763 and all serial numbers
ClassificationClass II
Reason for RecallTerumo 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 Quantity1647 units total
Recall NumberZ-0435-2013
Product Description220/240V 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 InfoCatalog number: 801764 and all serial numbers
ClassificationClass II
Reason for RecallTerumo 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 Quantity1647 units total
Recall NumberZ-0436-2013

Class II Devices Event

Event ID63544
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide 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 DescriptionNexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen® 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 InfoCatalog 00-5986-047-02, lots 62049114 and 62045235.
ClassificationClass II
Reason for RecallZimmer 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 Quantity123 worldwide (33 USA)
Recall NumberZ-0437-2013

Class II Devices Event

Event ID63583
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMetrex Research, LLC.
CityRomulus
StateMI
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
 

Associated Products

Product DescriptionPentron 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 InfoPart Number Lot Number 4511 201008270110
ClassificationClass II
Reason for RecallThe 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 Quantity3,348 units
Recall NumberZ-0444-2013

Class II Drugs Event

Event ID63630
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoehringer Ingelheim Roxane Inc
CityColumbus
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Code InfoLot 201900 Expiration Date: JAN 2015
ClassificationClass II
Reason for RecallDefective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Product Quantity8,381 bottles
Recall NumberD-067-2013

Class II Devices Event

Event ID63649
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Sep-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKimberly-Clark Corporation
CityRoswell
StateGA
CountryUS
Distribution PatternNationwide 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 DescriptionKimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Code InfoSerial 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
ClassificationClass II
Reason for RecallError 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Product Quantity400 units
Recall NumberZ-0451-2013

Class II Drugs Event

Event ID63661
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmProcter & Gamble Co
CityMason
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionVicks 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 .
ClassificationClass II
Reason for RecallLabeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Product Quantity17,532 bottles
Recall NumberD-069-2013

Class II Devices Event

Event ID63675
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIradimed Corporation
CityWinter Park
StateFL
CountryUS
Distribution PatternNationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
 

Associated Products

Product DescriptionThe 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 InfoThe 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.
ClassificationClass II
Reason for RecallIradimed 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 Quantity719 sets
Recall NumberZ-0446-2013

Class II Devices Event

Event ID63681
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCooper Surgical, Inc.
CityTrumbull
StateCT
CountryUS
Distribution PatternWorldwide 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 DescriptionCooper 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 InfoAll serial numbers
ClassificationClass II
Reason for RecallExcessive 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 Quantity1215 total
Recall NumberZ-0439-2013
Product DescriptionCooper 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 InfoArch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
ClassificationClass II
Reason for RecallExcessive 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 Quantity1215 total
Recall NumberZ-0440-2013

Class II Drugs Event

Event ID63691
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlaxoSmithKline, LLC.
CityZebulon
StateNC
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionArranon (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 InfoLot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
ClassificationClass II
Reason for RecallImpurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Product Quantity1,319 vials
Recall NumberD-068-2013

Class II Devices Event

Event ID63711
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide distribution: USA including states of: AZ, MD, and KS.
 

Associated Products

Product DescriptionEcho 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 InfoCatalog Number: 192411 and Lot Number Identification: 244800
ClassificationClass II
Reason for RecallIt was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Product Quantity4
Recall NumberZ-0442-2013

Class II Devices Event

Event ID63722
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Navigation, Inc.
CityLouisville
StateCO
CountryUS
Distribution PatternWorldwide 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 DescriptionThe 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 InfoLot number 120203.
ClassificationClass II
Reason for RecallMedtronic 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 Quantity12 Units
Recall NumberZ-0441-2013

Class II Drugs Event

Event ID63759
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRanbaxy Inc.
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide and PR
 

Associated Products

Product DescriptionAtorvastatin 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 InfoLot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
ClassificationClass II
Reason for RecallPresence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity120,201 Bottles
Recall NumberD-070-2013
Product DescriptionAtorvastatin 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 InfoLot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.
ClassificationClass II
Reason for RecallPresence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity203,198 Bottles
Recall NumberD-071-2013
Product DescriptionAtorvastatin 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 Infoa) 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.
ClassificationClass II
Reason for RecallPresence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Quantity157,026 Bottles
Recall NumberD-072-2013

Class III Biologics Event

Event ID48247
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07OUTF1661; 07OUTF2092; 07OUTF3219; 08OUTF2071; 08OUTF4413; 08OUTF5051; 08OUTF5772; 08OUTF6290; 08OUTF6931; 07OUTF4170; 07OUTF4787; 2473; 08OUTF7761; 08OUTF8282
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity14 units
Recall NumberB-0089-13

Class III Biologics Event

Event ID62937
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida Blood Services, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Washed
Code InfoW11631271022400;
ClassificationClass III
Reason for RecallBlood product, which was washed with an incorrect wash solution, was distributed.
Product Quantity1 unit
Recall NumberB-0004-13

Class III Biologics Event

Event ID62959
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityAlexandria
StateLA
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036512069578;
ClassificationClass III
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-0001-13

Class III Drugs Event

Event ID63707
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlaxoSmithKline, LLC.
CityZebulon
StateNC
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionAdvair 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 InfoLot #: 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.
ClassificationClass III
Reason for RecallProduct Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Quantity310,964 Aerosol Units
Recall NumberD-064-2013
Product DescriptionAdvair 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 Info1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
ClassificationClass III
Reason for RecallProduct Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Quantity18,676 Aerosol Units
Recall NumberD-065-2013
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