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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Class I Food Event

Event ID51894
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Apr-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTrophy Nut Co Inc
CityTipp City
StateOH
CountryUS
Distribution PatternDistributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.
 

Associated Products

Product DescriptionTrophy Nut Brand 1.5 oz. tube; Trophy Nut Brand 1.25 oz. tube; Nut Barrel Brand 5 oz. Fundraising bag; and Nut Barrel Brand 1.25 oz. tube.
Code InfoTrophy Nut Brand 1.5 oz. tube UPC 74249-50778 Code Date 8/9/2009 thru 11/3/2009; Trophy Nut Brand 1.25 oz. tube UPC 74249-89778 Code Date 8/16/2009 thru 10/13/2009; Nut Barrel Brand 5 oz. Fundraising bag UPC 74249-44267 Code Date 0449, 0709, and 0139; Nut Barrel Brand 1.25 oz. tube UPC 74249-27778 Code Date 8/16/2009 thru 10/13/2009.
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Product Quantity45,518 lbs
Recall NumberF-1518-2013
Product DescriptionTrophy Nut Brand 1.5 oz. Red Pistachio Tube and Nut Barrel Brand 1.25 oz. Red Pistachio Tube.
Code InfoTrophy Nut Brand 1.5 oz. Red Pistachio Tube UPC 74249-50779 Code Date 08/16/2009 thru 10/27/2009 and Nut Barrel Brand 1.25 oz. Red Pistachio Tube UPC 74249-27779 Code Date 8/16/2009 thru 10/6/2009.
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1519-2013
Product DescriptionTrophy Nut Brand 6 oz. natural pistachios
Code InfoTrophy Nut Brand 6 oz. natural pistachios UPC 74249-19167 Code Date 0269
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1520-2013
Product DescriptionAmerica's Choice 9 oz. Giant Pistachios
Code InfoAmerica's Choice 9 oz. Giant Pistachios UPC 54807-51371 Code Date 1/19/2010 thru 1/23/2010
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1521-2013
Product DescriptionWa Wa brand 6 oz. Pistachio Gusset
Code InfoWa Wa brand 6 oz. Pistachio Gusset UPC 26191-07724 Code Date 11/15/2010 and 2/1/2010
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1522-2013

Class I Food Event

Event ID63738
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRio Queen Citrus, Inc
CityMission
StateTX
CountryUS
Distribution PatternTX, SC, KS, and Canada
 

Associated Products

Product DescriptionThe product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled "Karol" with the Lot No. "01W45" stamped in the upper, right-hand corner on the face of the box. The box states "Distributed by Interstate Fruit & Vegetable", which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container depending on the area and retailer.
Code InfoLot No. "01W45"
ClassificationClass I
Reason for RecallRio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in "Karol" brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product Quantity840 cases (12 pints per case)
Recall NumberF-1517-2013

Class I Biologics Event

Event ID63909
StatusCompleted
Product TypeBiologics
Voluntary/Mandated FDA Mandated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPacific Coast Tissue Bank
CityLos Angeles
StateCA
CountryUS
Distribution Patternnationwide and world wide
 

Associated Products

Product DescriptionItem 27f
Code InfoBatch Numbers: 09104, 09106, 09114, 09115, 10115, 11103, 11117
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity4,146 units
Recall NumberB-1546-13
Product DescriptionItem 27g
Code InfoBatch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10115, 11103, 11117, 11118, 12102
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity6,896 units
Recall NumberB-1547-13
Product DescriptionItem 70a
Code InfoBatch Numbers: 09105, 09107, 09108, 09109, 09111, 09112, 09121, 10101, 10102, 10104, 10107, 10110, 10111, 10112, 10113, 10114, 10117, 10118
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity13,069 units
Recall NumberB-1548-13
Product DescriptionItem 70
Code InfoBatch Numbers: 09102, 09105, 09107, 09108, 09110, 09112, 09113, 09118, 10101, 10103, 10104, 10105, 10106, 10107, 10108, 10110, 10112, 10113, 10114, 10116, 10117
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity10,630 units
Recall NumberB-1549-13
Product DescriptionItem 71
Code InfoBatch Numbers: 09102, 09105, 09107, 09108, 09109, 09110, 09111, 09112, 09113, 09118, 09121, 10101, 10113
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity2,038 units
Recall NumberB-1550-13
Product DescriptionItem 80a
Code InfoBatch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10116
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity3,126 units
Recall NumberB-1551-13
Product DescriptionItem 83cx
Code InfoBatch Numbers: 09109, 09110, 09111
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity264 units
Recall NumberB-1552-13
Product DescriptionItem 80a
Code InfoBatch Numbers: 091116
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity194 allografts
Recall NumberB-1553-13
Product DescriptionItem 27f
Code InfoBatch Numbers: 09116
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity814 allografts
Recall NumberB-1554-13
Product DescriptionItem 27g
Code InfoBatch Numbers: 09116
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity152 allografts
Recall NumberB-1555-13
Product DescriptionItem 70
Code InfoBatch Numbers: 09119, 19120
ClassificationClass I
Reason for RecallHuman tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Product Quantity1,594 allografts
Recall NumberB-1556-13

Class I Drugs Event

Event ID63988
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAdvance Pharmaceutical Inc
CityHoltsville
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionRugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
Code InfoLot 12G468, Exp. 07/2014.
ClassificationClass I
Reason for RecallLabeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Product Quantity19,944 bottles
Recall NumberD-601-2013

Class I Food Event

Event ID64016
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthwest Ice Cream Specialties
CityMckinney
StateTX
CountryUS
Distribution PatternProduct was distributed in the following states: Arkansas, Arizona, Colorado, Kansas, Oklahoma, New Mexico and Texas.
 

Associated Products

Product Description"Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)" is displayed on the carton's label in error. The lid bears the label "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS (1.661L)". The product bears UPC 015400224840, a Best Buy date of NOV 8, 2014, and a Plant Code of 48-3202-F.
Code InfoUPC 015400224840, Best by NOV 8, 2014, and Plant Code 48-3202-F
ClassificationClass I
Reason for RecallProduct may contain undeclared pecan, soy, and/or wheat allergens.
Product Quantity1,524 cartons
Recall NumberF-1527-2013

Class I Drugs Event

Event ID64409
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOLAAX International
CityBartow
StateFL
CountryUS
Distribution PatternNationwide, Puerto Rico and Venezuela and Bolivia
 

Associated Products

Product DescriptionMAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Code InfoAll Lots
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Product Quantity600 boxes
Recall NumberD-600-2013

Class I Veterinary Event

Event ID64551
StatusTerminated
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDiggin Your Dog, LLC
CityReno
StateNV
CountryUS
Distribution PatternNV and CO
 

Associated Products

Product DescriptionDiggin Your Dog Strippin Chicks; USA Chicken Charki Strips for Dogs 100% Grown, Raised, Harvested in USA. Net Wt. 5 oz. Ingredients: Chicken, Vitamin E Supplement. UPC: 6-09788-82324-7 Diggin Your Dog USA, Reno, NV
Code InfoLot Code # 250322 and USE BY 2-23-14
ClassificationClass I
Reason for RecallColorado Department of Agriculture collected a sample of Diggin Your Dog Brand Strippin Chicks at retail and had a positive result for Salmonella.
Product Quantity45 cases ( 12 x 5 oz. packages per case)
Recall NumberV-208-2013

Class I Biologics Event

Event ID65027
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlloSource, Inc.
CityCentennial
StateCO
CountryUS
Distribution PatternMichigan; Alabama; North Carolina
 

Associated Products

Product DescriptionBone
Code Info123437106; 123437107; 123437109; 123437110; 123437111; 123437113; 123437114; 123437115; 123437116; 123437117; 123437118; 123437119; 123437126; 123437129; 123437130
ClassificationClass I
Reason for RecallHuman tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity15 allografts
Recall NumberB-1649-13

Class I Food Event

Event ID65059
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPure Herbs Ltd
CitySterling Heights
StateMI
CountryUS
Distribution PatternThe Pure Herbs products are sold to a network of independent distributors/consumers.
 

Associated Products

Product DescriptionPure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.
Code InfoLot codes being recalled are lots 243 and 050812, 012712A.. All Protein products manufactured prior to lot 243 are being recalled. Unfortunately the firm does not have records to indicate the lot numbers prior to lot 243.
ClassificationClass I
Reason for RecallPure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Product Quantity813 x 4oz bottles and 72 x 1oz bottles
Recall NumberF-1505-2013

Class I Food Event

Event ID65099
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHazelnut Growers of Oregon
CityCornelius
StateOR
CountryUS
Distribution Patterndistributed in Canada only.
 

Associated Products

Product DescriptionJumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in parts: "***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO. 1***Hazelnut Growers of Oregon***401 N. 26 Avenue, Cornelius, Oregon 97113***".
Code InfoLot A102112. This code represents day shift, date of production is October 21, 2012. There is no expiration date on the product.
ClassificationClass I
Reason for RecallLarge and Jumbo in-shell Barcelona Hazelnuts (50 lbs. bulk bags) are recalled due to a potential contamination with Salmonella.
Product Quantity5000 lbs. Jumbo Barcelona and 5000 lbs. Large Barcelona in-shell hazelnuts
Recall NumberF-1532-2013

Class I Food Event

Event ID65128
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAtlantic Pro Nutrients, Inc. dba XYMOGEN
CityOrlando
StateFL
CountryUS
Distribution PatternAK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia and Hawaii
 

Associated Products

Product DescriptionXYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles
Code InfoAll SKUs
ClassificationClass I
Reason for RecallUndeclared Soy and Milk on the label.
Product Quantity16,268 units
Recall NumberF-1523-2013

Class I Food Event

Event ID65142
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDairy Fresh LLC
CityWinston Salem
StateNC
CountryUS
Distribution PatternFL, GA KY, NC, OH, PA, SC, TN and WV.
 

Associated Products

Product Description IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart
Code InfoUPC #4137046131, Plant Code 3783, Sell by dates: 06-08-13 07-19-13, 08-02-13, 08-13-13 and 08-27-13.
ClassificationClass I
Reason for RecallUndeclared allergens: Almonds, Coconut, Soy Lecithin
Product Quantity10,050 cartons
Recall NumberF-1526-2013

Class I Devices Event

Event ID65248
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEndologix Inc
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
 

Associated Products

Product DescriptionBrand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Code InfoModel Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
ClassificationClass I
Reason for RecallEndologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Product Quantity53
Recall NumberZ-1436-2013

Class I Food Event

Event ID65291
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBlessing Seafood, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternThe 16-20 EZ Peel Shrimp was distributed by Perishable Distributors of Iowa (PDI) and sold from February 12 to May 23, 2013 at the seafood display counters in the retail markets seafood section of Hy-Vee stores located in eight states: Iowa, Nebraska, Kansas, Illinois, Missouri, South Dakota, Minnesota, and Wisconsin, and at Cedar Valley Fish Market in Waterloo, Iowa.
 

Associated Products

Product DescriptionBlessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton. The product is sold in a seafood retail case. Product labeled as:"WILD WHITE EZ PEEL SHRIMP 16/20 CT WILD CAUGHT PRODUCT OF USA CHEM FREE INGREDIENTS: Shrimp, Salt***PACKED BY: BLESSINGS, INC.***.
Code InfoLot # 13047-1, 13048-1, and 13048-3
ClassificationClass I
Reason for RecallBlessing Seafood, Inc. is voluntarily recalling one lot of Blessing Inc. Wild White EZ Peel Shrimp due to undeclared sulfites.
Product Quantity36,920 lbs
Recall NumberF-1528-2013

Class I Food Event

Event ID65299
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFruit Treasure Inc
CitySan Diego
StateCA
CountryUS
Distribution PatternWithin California.
 

Associated Products

Product DescriptionFresh Thai chili peppers. Loose fresh Thai chili peppers packaged with inner plastic mesh bag into paper carton cardboard boxes. Imported bulk. Outer carton labeling reads in part: "***PRODUCE OF MEXICO***JAMMIN PEPPERS***THAI CHILI***DISTRIBUTED BY: JT BROKERAGE 651 KOHLER ST. LOS ANGELES, CA 90021***WWW.JAMMINPEPPERS.COM***".
Code InfoBulk outer carton labelets with Lot # 162. Sold to retail with no coding or marks.
ClassificationClass I
Reason for RecallThe firm recalled the Thai chili peppers because FDA analytical results revealed the presence of Salmonella.
Product Quantity25 lb-43cartons
Recall NumberF-1524-2013

Class I Food Event

Event ID65335
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmInternational Desserts and Delicacies
CityGlendale
StateCA
CountryUS
Distribution PatternNationwide to retail grocery stores.
 

Associated Products

Product DescriptionUncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:"uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www.vegancookies.com***".
Code Info Lot numbers #110813, and #58513
ClassificationClass I
Reason for RecallInternational Desserts of Glendale, California is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies in 12 oz bags, because it may contain undeclared walnuts.
Product Quantity540 bags
Recall NumberF-1525-2013

Class II Biologics Event

Event ID39536
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets
Code Info1699871
ClassificationClass II
Reason for RecallPlatelet, with an unacceptable pH, was distributed.
Product Quantity1 unit
Recall NumberB-1369-13

Class II Biologics Event

Event ID39738
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services LP
CitySpringfield
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info04FMOA1901; 04FMOA1730; 04FMOA1310; 04FMOA1176; 04FMOB1359; 04FMOB1509; 04FMOB1815
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity7 Units
Recall NumberB-1450-13

Class II Biologics Event

Event ID43953
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2238974(Part A); 2238974(Part B); 2238974(Part C)
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Product Quantity3 units
Recall NumberB-1389-13

Class II Biologics Event

Event ID45833
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoV71278
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-1373-13

Class II Biologics Event

Event ID45834
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Sep-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoK14065
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-1374-13

Class II Biologics Event

Event ID47052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code Info2409017
ClassificationClass II
Reason for RecallBlood products, which was identified as being contaminated by the BacT/ALERT system, was distributed.
Product Quantity1 unit
Recall NumberB-1390-13

Class II Biologics Event

Event ID47054
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida, New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2401160
ClassificationClass II
Reason for RecallBlood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
Product Quantity1 unit
Recall NumberB-1391-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info2401160
ClassificationClass II
Reason for RecallBlood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
Product Quantity1 unit
Recall NumberB-1392-13

Class II Biologics Event

Event ID47055
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2409193(Part A); 2409193(Part B)
ClassificationClass II
Reason for RecallBlood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
Product Quantity2 units
Recall NumberB-1393-13

Class II Biologics Event

Event ID47268
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2923709
ClassificationClass II
Reason for RecallBlood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed.
Product Quantity1 unit
Recall NumberB-1394-13

Class II Biologics Event

Event ID47270
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2582623
ClassificationClass II
Reason for RecallBlood products, which gave a positive result by the BacT system, were distributed.
Product Quantity1 unit
Recall NumberB-1395-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2582623
ClassificationClass II
Reason for RecallBlood products, which gave a positive result by the BacT system, were distributed.
Product Quantity1 unit
Recall NumberB-1396-13

Class II Biologics Event

Event ID47271
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2554254(Part A); 2554254(Part B)
ClassificationClass II
Reason for RecallBlood products, with positive bacterial detection testing, were distributed.
Product Quantity2 units
Recall NumberB-1397-13

Class II Biologics Event

Event ID47272
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2626418
ClassificationClass II
Reason for RecallBlood product, with positive bacterial detection testing, was distributed.
Product Quantity1 unit
Recall NumberB-1398-13

Class II Biologics Event

Event ID52245
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Apr-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services LP
CityCoralville
StateIA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08IIAE8374; 08IIAE7282; 08IIAE6595; 08IIAH2718; 08IIAH2425; 08IIAH1074; 08IIAH0557; 08IIAG9210; 08IIAG8336; 08IIAG7285; 08IIAG5669; 08IIAG5288; 08IIAG3787; 08IIAG3355; 08IIAG1886; 08IIAG1450; 08IIAF3267; 08IIAF2468; 08IIAE5604; 08IIAE5050; 08IIAE3681; 08IIAE2740; 08IIAE1500; 08IIAE0848; 08IIAD9640; 08IIAD8918; 08IIAD7411; 08IIAD6779; 08IIAD6080; 08IIAD5535; 08IIAD4770; 08IIAD3972; 08IIAD2489; 08IIAD1217; 08IIAD0504; 08IIAD0018; 08IIAC7994; 08IIAC7250; 08IIAC5888; 08IIAC5172; 08IIAC0381; 08IIAB9637; 08IIAB8792; 08IIAB7823; 08IIAB5804; 08IIAB5391; 08IIAB4303; 08IIAB3433; 08IIAB2935; 08IIAB2212; 07IIAA4595; 07IIAA1170; 07IIAA0797; 07IIAA0285; 06IIAC4233; 06IIAC3869
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity56 Units
Recall NumberB-1375-13

Class II Biologics Event

Event ID57222
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710012578
ClassificationClass II
Reason for RecallBlood product, collected from a donor based on travel to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-1376-13

Class II Food Event

Event ID63937
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternDomestically, nationwide, and to Canada and the United Kingdom.
 

Associated Products

Product DescriptionNatures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106
Code InfoBest by June 12, 13, and 14, 2013
ClassificationClass II
Reason for RecallThe product has the potential to contain undeclared almond slices.
Product Quantity411 cases
Recall NumberF-1531-2013

Class II Veterinary Event

Event ID64061
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDel Monte Foods Corp
CitySan Francisco
StateCA
CountryUS
Distribution PatternNationally to >200 consignees
 

Associated Products

Product DescriptionAll Sizes Milo's Kitchen home style dog treats - Chicken Jerky 3.3 oz UPC 079100504718, 14 oz. UPC 079100510771, 20 oz. UPC 079100504688
Code InfoUPC:079100504718; UPC:079100510771; UPC:079100504688
ClassificationClass II
Reason for RecallOn 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milos Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.
Product Quantity1.97 MM
Recall NumberV-196-2013
Product DescriptionAll Sizes: Milo's Kitchen brand Chicken Grillers home style dog treats; Chicken Recipe with natural smoked flavor. 3.3 oz UPC 079100513109; 14 oz. UPC 079100513123; 20 oz UPC 079100513130.
Code InfoUPC ITEM CODES: UPC 079100513109; UPC 079100513123; UPC 079100513130
ClassificationClass II
Reason for RecallOn 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milo's Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.
Product Quantity.43 MM cases
Recall NumberV-197-2013

Class II Veterinary Event

Event ID64064
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmIMS Trading Corp.
CityWood Ridge
StateNJ
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionCadet Gourmet Chicken Breast a) Net Wt. 3.6 oz UPC 768303074929 b) Net Wt. 8 oz. UPC 768303074936 c) Net Wt. 1 Lb (454 g) tub - UPC 768303014352 UPC 768303014703 d) Net Wt. 1.25 Lb (567 g) UPC 768303014741 e) Net Wt. 1.5 Lb (681 g) UPC 768303014161 f) Net. Wt. 2.0 lb. UPC 768303014727 Product of China Not for Human Consumption. Distributed by: IMS Pet Industries, Inc., 34 Passaic Street, Wood-Ridge, NJ 07075
Code InfoAll codes
ClassificationClass II
Reason for RecallNYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.
Product Quantity3.6 oz - 17,408 units; 8 oz. - 3,403 units; 1 lb. - 21540 units; 1.25 lb. -198 units; 1.5 lb - 300 units; 2.0 lb- 19,261 units
Recall NumberV-204-2013
Product DescriptionShep Chicken Breast Fillets Net Wt. 3.5 oz (99g) Net Wt. 3. oz (99g) Product of China. Not for Human Consumption. Distributed by: ALDI Inc. Batavia, IL 60510-1477
Code InfoAll codes
ClassificationClass II
Reason for RecallNYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.
Product Quantity159,744 units;
Recall NumberV-205-2013
Product DescriptionHome 360 Pet Chicken Breast Fillets Oven Roasted a) Net Wt. 3.5 oz (99g) UPC 725439966429 b) Net Wt. 1 Lb (454 g) UPC 725439966436 Product of China. Not for Human Consumption. Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147 Product of China
Code InfoAll codes
ClassificationClass II
Reason for RecallNYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.
Product Quantity
Recall NumberV-206-2013
Product DescriptionCompanion Chicken Breast Fillet Jerky Strips Dog Treats a) Net Wt 3.3 oz (94 g) . UPC 688267076862 b) Net Wt 14 oz (397g) UPC 688267077449 Distributed by Foodhold USA, LLC Landover, MD 20785 Product of China
Code InfoAll codes
ClassificationClass II
Reason for RecallNYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.
Product Quantity3.3 oz - 17,280 units; 14 oz. - 13,260 units
Recall NumberV-207-2013

Class II Biologics Event

Event ID64176
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmOur Lady Of The Lake Hospital Inc
CityBaton Rouge
StateLA
CountryUS
Distribution Pattern5 in Louisiana
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW1657120277545 (Part 1), W1657120277545 (Part 2), W165712023964C Bag 1, W165712023964C Bag 2
ClassificationClass II
Reason for RecallBlood products, collected from a potentially ineligible donor, were distributed.
Product Quantity4 units
Recall NumberB-1582-13
Product DescriptionFresh Frozen Plasma
Code InfoW1657120266156, W165712026601I, W165712026599B, W165712024396S, W165712024395U, W165712024393Y, W1657120243903, W165712024368*, W1657120243671, W1657120243655, W1657120243647, W1657120250687, W165712024819E, W165712023827U, W165712027716H, W165712027712P, W165712027704P, W165712027700X, W1657120214666, W1657120213053, W165712021364I, W165712020867P, W165712019069A, W165712000939F, W165712019313Y, W165712018284C, W1657120182151, W165712018196C, W165712018100N, W165712018099E, W165712018097I, W1657120101824, W165712015088V, W165712016583M, W1657120149183, W165712007005W, W165712006336A, W165712006225O, W165712013834R, W165712013658R, W165712010491F, W165712010967C, W165712010925W, W165711028973L, W165712010427V, W1657120104240, W165712008629Q, W165712007439H, W165712006880*, W165712005346I, W165712005429G, W165712004663C, W1657120046101, W165712004483K, W165712004307F, W1657120023997, W1657120023989, W165712002389B, W165712002383N, W165712002376L, W165712000189M, W1657120213205, W1657120195793, W165712022369T, W1657120189617, W165712025372S, W165712000927N, W1657120009008, W165712018308S, W1657120182868, W165712018171U, W165712018106B, W1657120106401, W165712010637B, W165712010563F, W1657120099697, W1657120099140, W165712009810G, W165712018318Q, W165712016555U, W165712007447H, W165712007446J, W165712007008Q, W165712007007S, W165712006981Q, W165712006963U, W1657120132181, W165712011854E, W165712006093G, W165712010960Q, W165712009948H, W1657120102616, W165712009811E, W1657120098340, W1657120100960, W1657120100864, W165712010243A, W165712010177Z, W1657120101664, W165712008483U, W165712008705Y, W165712007432V, W165712007391H, W1657120061938, W165712002380T, W165712013501W, W165712024191H, W1657120146114, W165712016584K, W165712018007H, W1657120182876, W165712016589A
ClassificationClass II
Reason for RecallBlood products, collected from a potentially ineligible donor, were distributed.
Product Quantity112 units
Recall NumberB-1583-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW165712027965K, W165712027847W, W1657120268020, W1657120275793, W1657120243743, W165712024360F, W165712024396S, W165712024368, W1657120243663, W1657120243655, W1657120243647, W1657120243639, W165712027902D, W165712026691J, W1657120266228, W165712026191M, W1657120266164, W165712024260N, W1657120284020, W165712026586L
ClassificationClass II
Reason for RecallBlood products, collected from a potentially ineligible donor, were distributed.
Product Quantity20 units
Recall NumberB-1584-13

Class II Veterinary Event

Event ID64212
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHartz Mountain Corp.
CitySecaucus
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionHartz Oinkies wraps with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists - 3.1 oz UPC 3270003354 7 mini pig skin twists - 6 oz.
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics
Product Quantity5 pack - 38,762 units; 7 pack - 42,258 units
Recall NumberV-198-2013
Product DescriptionHartz Oinkies Pig Skin Twists wrapped with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists UPC 3270003354 7 mini pig twists UPC 3270003330 15 mini pig skin twists - 11.4 oz UPC 3270003331 20 pig skin twists - 4.9 oz. UPC 32700-13472
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics
Product Quantity5 pack - 38,672 units; 7 pack - 42,258 units; 15 pack -49070 units; 20 pack - 30,912 units
Recall NumberV-199-2013
Product DescriptionHartz Chicken Chews Soft and Tender Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 3.5 oz. - UPC 3270011966 Net Wt. 8 oz - UPC 3270011967 Net Wt. 16 oz. - UPC 3270011953 Net Wt. 24 oz. - UPC 3270011954
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics
Product Quantity3.5 oz. - 17610 units; 8 oz. - 26,202 units; 16 oz - 9,937 units; 24 oz. - 17,593 units
Recall NumberV-200-2013
Product DescriptionHartz Chicken Chews Bite Size Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 5.7 oz. - UPC 3270012856 Net Wt. 16 oz - UPC 3270012765
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics
Product Quantity5.7 oz -7,094 units; 16 oz - 6,301 units;
Recall NumberV-201-2013
Product DescriptionPet Pride Chicken Breast Jerky Distributed by: The Kroger Co. Cincinnati OH, Made In China Net Wt. 16 oz. - UPC 1111087994 Net Wt. 24 oz - UPC 1111079250
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics
Product Quantity16 oz. - 34,704 units; 24 oz. - 50,364 units
Recall NumberV-202-2013
Product DescriptionExer-hides Rawhide Twists Distributed by Wal-Mart Stores, Inc.. Bentonville, AR 72716 Made in China 25 pack 5" twists. Net Wt. 6 oz. UPC 8113143905
Code InfoAll codes
ClassificationClass II
Reason for RecallPet treats contain unapproved antibiotics.
Product Quantity593,420 units
Recall NumberV-203-2013

Class II Devices Event

Event ID64276
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBard Peripheral Vascular Inc
CityTempe
StateAZ
CountryUS
Distribution PatternNationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
 

Associated Products

Product DescriptionBARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip® Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Code InfoPC 864017D; Lots: HUWK1296, HUWK1297
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
Product Quantity815
Recall NumberZ-1526-2013
Product DescriptionBARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip® Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Code InfoPC 863017D; Lot: HUWL0010
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
Product Quantity315
Recall NumberZ-1527-2013
Product DescriptionMICROSHEATH® - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath® is a single lumen catheter that has a 123cm working length and a straight tip shape
Code InfoPC MS17123; Lot# FCWC10010
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
Product Quantity17
Recall NumberZ-1528-2013
Product DescriptionUSHER® Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher® Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher® Peripheral is available in a length 130 cm with an angled tip shape.
Code InfoPC USH07AT; Lot# FCWC10009
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
Product Quantity223
Recall NumberZ-1529-2013

Class II Biologics Event

Event ID64380
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Blood Services Inc.
CityFlowood
StateMS
CountryUS
Distribution PatternMississippi
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW069112127383;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.
Product Quantity1
Recall NumberB-1179-13

Class II Biologics Event

Event ID64381
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW280312101666;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.
Product Quantity1
Recall NumberB-1180-13

Class II Biologics Event

Event ID64400
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW333612086754;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1181-13

Class II Biologics Event

Event ID64414
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBio-Blood Components, Inc.
CityHammond
StateIN
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info12HINC8697;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was suspected of receiving a piercing within 12 months of donating, was distributed.
Product Quantity1
Recall NumberB-1183-13

Class II Biologics Event

Event ID64415
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWisconsin; Arkansas
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036312107843; W036312107843; W036312107843;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was taking Plavix, were distributed.
Product Quantity3
Recall NumberB-1184-13

Class II Biologics Event

Event ID64522
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045012008981
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-1489-13

Class II Biologics Event

Event ID64524
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW041013009100L
ClassificationClass II
Reason for RecallBlood product, with a low platelet concentration, was distributed.
Product Quantity1 unit
Recall NumberB-1488-13

Class II Biologics Event

Event ID64526
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112319673
ClassificationClass II
Reason for RecallBlood products, collected from a donor who deferred for receiving a piercing, were distributed.
Product Quantity1 unit
Recall NumberB-1490-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW038112319673
ClassificationClass II
Reason for RecallBlood products, collected from a donor who deferred for receiving a piercing, were distributed.
Product Quantity1 unit
Recall NumberB-1491-13

Class II Biologics Event

Event ID64574
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals Carbondale, LLC
CityCarbondale
StateIL
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code InfoCD0371015; CD0371217; CD0371723; CD0371909;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had been incarcerated, were distributed.
Product Quantity4
Recall NumberB-1493-13

Class II Biologics Event

Event ID64575
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW037711189379;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1476-13

Class II Biologics Event

Event ID64590
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMercy Hospital St Louis
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionWhole Blood Leukocytes Reduced
Code InfoW069613000559;
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1481-13

Class II Biologics Event

Event ID64742
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeShare Blood Centers
CityMonroe
StateLA
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512134905
ClassificationClass II
Reason for RecallBlood product, collected from a donor who visited a malarial endemic region, was distributed.
Product Quantity1 unit
Recall NumberB-1781-13

Class II Food Event

Event ID64834
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPurely American, Inc.
CityAthens
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.
 

Associated Products

Product DescriptionChicken Noodle Soup Mix, "9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8 and World's Best Teacher UPC 7 92290 00196 5.
Code InfoITEM # CA103 and ITEM #179
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity278/9 oz cello bags
Recall NumberF-1506-2013
Product DescriptionPasta Salad Mix, "10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, parsley, celery seed, garlic, paprika, and spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PICNIC AT CAPE MAY UPC 7 92290 00143 9 and PICNIC AT FAIRMOUNT PARK UPC 7 92290 00138 5.
Code InfoITEM # CA104, ITEM #146, ITEM #143, ITEM #145 and ITEM #138
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity91/10 oz cello bags
Recall NumberF-1507-2013
Product DescriptionPasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes and garlic***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: LIGHTS OF LAKE ERIE 10 oz cello bag, UPC 7 92290 00188 0, LIGHTS OF CAROLINA 10 oz cello bag, UPC 7 92290 00155 2, LIGHTS OF THE CHESAPEAKE 11 oz cello bag, UPC 7 92290 00160 6 and LIGHTS OF LAKE MICHIGAN 11 oz cello bag UPC 7 92290 00169 9
Code InfoITEM #188, ITEM #155, ITEM #160 and ITEM #169
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity163/10 oz cello bags & 176/11 oz cello bags
Recall NumberF-1508-2013
Product DescriptionADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes, and garlic.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00164 9
Code InfoITEM #164
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity20/11 oz cello bags
Recall NumberF-1509-2013
Product DescriptionGILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, black pepper, garlic powder, salt.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00153 8
Code InfoITEM #153
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity73/15 oz cello bags
Recall NumberF-1510-2013
Product DescriptionLONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00178 1
Code InfoITEM #178
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity60/15 oz cello bags
Recall NumberF-1511-2013
Product DescriptionMAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00105 7
Code InfoITEM #105
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity413/15 oz cello bags
Recall NumberF-1512-2013
Product DescriptionSANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell peppers, celery & parsley flakes, non-aluminum baking powder, baking soda, salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00126 2
Code InfoITEM #126
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity63/12.25 oz coffee bags
Recall NumberF-1513-2013
Product DescriptionINDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange peel, baking powder, and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00135 4
Code InfoITEM #135
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity25/17 oz coffee bags
Recall NumberF-1514-2013
Product DescriptionSHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00121 7
Code InfoITEM #121
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity230/15.5 oz coffee bags
Recall NumberF-1515-2013
Product DescriptionMARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00131 6
Code InfoITEM #131
ClassificationClass II
Reason for RecallThe firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.
Product Quantity1/18.5 oz coffee bag
Recall NumberF-1516-2013

Class II Biologics Event

Event ID64890
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Bct
CityLakewood
StateCO
CountryUS
Distribution PatternNational and global distribution.
 

Associated Products

Product DescriptionTrima Accel Automated Blood Component Collection System, catalog number 81000, all serial numbers, with software versions prior to 5.1.9 and 6.0.6.
Code InfoCatalog number 81000, ALL SERIAL NUMBERS.
ClassificationClass II
Reason for RecallTerumo BCT's Trima Accel systems, with a potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system, were distributed.
Product Quantity3074 units
Recall NumberB-1670-13

Class II Devices Event

Event ID65046
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBard Peripheral Vascular Inc
CityTempe
StateAZ
CountryUS
Distribution PatternWorldwide Distribution: USA Nationwide and Internationally to Europe.
 

Associated Products

Product DescriptionBARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
Code InfoAffected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.
Product Quantity3,085
Recall NumberZ-1524-2013

Class II Devices Event

Event ID65081
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
 

Associated Products

Product DescriptionDePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Code InfoPart Number 230795000/Lot Number 5120443
ClassificationClass II
Reason for RecallThe Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
Product Quantity20 units
Recall NumberZ-1520-2013

Class II Devices Event

Event ID65091
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOrthoPediatrics Corp
CityWarsaw
StateIN
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product Description90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Code InfoAll lot numbers are affected. Catalog No. 00-1200-1000
ClassificationClass II
Reason for RecallPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Product Quantity130 devices were shipped
Recall NumberZ-1534-2013
Product Description90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Code InfoAll lot numbers are affected. Catalog No. 00-1200-1001
ClassificationClass II
Reason for RecallPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Product Quantity130 devices were shipped
Recall NumberZ-1535-2013
Product Description90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Code InfoAll lot numbers are affected. Catalog No. 00-1200-1002
ClassificationClass II
Reason for RecallPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Product Quantity130 devices were shipped
Recall NumberZ-1536-2013

Class II Devices Event

Event ID65108
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Optisurgical Inc
CityLake Forest
StateCA
CountryUS
Distribution PatternWorldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.
 

Associated Products

Product DescriptionTX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Code InfoLot Numbers: 00312-07 00713-06 00912-01 01813-02 02413-04 03113-02 04213-01 05113-01 05113-02 05512-03 05713-03 06313-05 06512-08 06513-02 07213-04 07912-06 08212-07 09412-03 11412-06 11612-05 12912-04 14512-07 15312-03 16412-07 17412-01 18712-06 19812-13 20212-03 21412-03 22212-03 23412-06 24112-06 24212-04 24912-13 25712-01 26912-01 27712-05 28512-03 28912-03 29612-01 30512-02 31112-05 32112-03 33112-01 34712-05 36612-01
ClassificationClass II
Reason for RecallAmerican Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
Product Quantity1,436 units
Recall NumberZ-1518-2013

Class II Devices Event

Event ID65173
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEdwards Lifesciences, LLC
CityDraper
StateUT
CountryUS
Distribution PatternWorldwide distribution: US Nationwide and country of Canada.
 

Associated Products

Product DescriptionQuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona­ pyrogenic in a sealed, peel-type pouch.
Code InfoModel QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841 Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853
ClassificationClass II
Reason for RecallEdwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.
Product Quantity22,616
Recall NumberZ-1542-2013

Class II Devices Event

Event ID65175
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEmbla System Llc
CityTonawanda
StateNY
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada.
 

Associated Products

Product Descriptionembla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772
Code InfoSerial Numbers: EBG-C1000497 C0914092-EBG EBG-C1002589 EBG-C1002598 EBG-C1001659 EBG-C1001832 EBG-C1001835 EBG-C1001843 EBG-C1001845 EBG-C1002253 EBG-C1002473 EBG-C1002504 EBG-C1002519 EBG-C1002537 EBG-C1002539 EBG-C1001367 EBG-C1001378 EBG-C1001763 EBG-C1000265 EBG-C1002607 EBG-C1002542 EBG-C1003212 EBG-C1001834 EBG-C1001858 EBG-C1001889 EBG-C1002445 EBG-C1003052 EBG-C1002502 EBG-C1002508 EBG-C1001776 C0901065-EBG EBG-C1003078 EBG-C1003084 EBG-C1003085 EBG-C1003161 EBG-C1003165 EBG-C1001230 EBG-C1001275 EBG-C1002688 EBG-C1002500 EBG-C1003055 EBG-C1001970 EBG-C1001972 EBG-C1001973 EBG-C1001983 EBG-C1001986 EBG-C1001518 EBG-C1000112 EBG-C1001308 EBG-C1002771 EBG-C1002863 EBG-c1001330 EBG-C1001237 C0901015-EBG EBG-C1000118 EBG-C1001394 EBG-C1001411 EBG-C1002871 EBG-C1003067 EBG-C1002602 EBG-C1002526 EBG-C1003206 EBG-C1002321 EBG-C1000100 EBG-C1000491 EBG-C1002376 EBG-C1000032 EBG-C1001303 EBG-C1002819 EBG-C1002920 EBG-C1002530 EBG-C1002538 EBG-C1000961 EBG-C1002912 C0914083-EBG C0917019-EBG EBG-C1002844 EBG-C1002864 EBG-C1002924 EBG-C1002935 EBG-C1001859 EBG-C1003024 EBG-C1000061 EBG-C1002532 EBG-C1001181 EBG-C1001376 EBG-C1001546 EBG-C1001374 EBG-C1001884 EBG-C1000565 EBG-C1000101 EBG-C1000144 EBG-C1000160 EBG-C1000085 EBG-C1001228 EBG-C1001346 EBG-C1001312 EBG-C1001205 EBG-C1002974 EBG-C1003162 EBG-C1001360 EBG-C1000015 EBG-C1000097 EBG-C1000473 EBG-C1001627 C0914068-EBG EBG-C1000987 EBG-C1000991 EBG-C1001000 EBG-C1001088 EBG-C1001097 EBG-C1001110 EBG-C1001121 EBG-C1001122 EBG-C1001123 EBG-C1001124 EBG-C1001134 EBG-C1001387 C0908065-EBG EBG-C1002250 EBG-C1002297 EBG-C1002309 EBG-C1002311 EBG-C1002460 EBG-C1002464 EBG-C1002469 C0837085-EBG EBG-C1000018 EBG-C1001847 EBG-C1001554 EBG-C1002371 EBG-C1002404 EBG-C1002409 EBG-C1002994 EBG-C1000002 EBG-C1000427 EBG-C1002588 EBG-C1002603 EBG-C1002842 EBG-C1002852 EBG-C1002862 EBG-C1002882 EBG-C1002886 EBG-C1002893 EBG-C1002933 EBG-C1002934 EBG-C1000574 EBG-C1003044 EBG-C1002890 EBG-C1001093 EBG-C1001094 EBG-C1001105 EBG-C1001107 EBG-C1001113 EBG-C1001125 EBG-C1001128 EBG-C1001129 EBG-C1001285 EBG-C1002263 EBG-C1002336 EBG-C1002448 EBG-C1002453 EBG-C1002462 C0826048-EBG EBG-C1001092 EBG-C1001280 EBG-C1001286 EBG-C1001680 EBG-C1002246 EBG-C1002279 EBG-C1002310 EBG-C1002312 EBG-C1002324 EBG-C1002333 EBG-C1002335 EBG-C1002451 EBG-C1002461 EBG-C1002466 EBG-C1002470 EBG-C1002475 EBG-C1000635 EBG-C1003445 EBG-C1001606 EBG-C1001519 EBG-C1000091 EBG-C1000383 EBG-C1001325 EBG-C1001391 C0917018-EBG EBG-C1001293 EBG-C1000034 EBG-C1002071 EBG-C1002939 EBG-C1002931 EBG-C1001297 EBG-C1003073 EBG-C1003156 EBG-C1002850 EBG-C1003193 EBG-C1003235 EBG-C1002544 C0845001-EBG EBG-C1000459 EBG-C1000485 EBG-C1000255 C0826010-EBG C0901029-EBG EBG-C1000281 EBG-C1001235 EBG-C1001825 C0826121-EBG EBG-C1002521 EBG-C1000025 EBG-C1000054 EBG-C1000080 EBG-C1000199 C0837087-EBG EBG-C1000104 C0837006-EBG C0901032-EBG C0917024-EBG C0914026-EBG EBG-C1000156 EBG-C1000108 EBG-C1003043 EBG-C1000103 EBG-C1000125 EBG-C1002290 EBG-C1002485 EBG-C1002506 EBG-C1000498 EBG-C1001967 EBG-C1000553 EBG-C1001989 EBG-C1001996 EBG-C1001998 EBG-C1001999 EBG-C1002000 EBG-C1002002 EBG-C1002003 EBG-C1002315 EBG-C1003468 EBG-C1000984 EBG-C1001024 EBG-C1001114 EBG-C1003418 EBG-C1002481 EBG-C1000935 EBG-C1002486 EBG-C1001133 EBG-C1001258 EBG-C1000062 EBG-C1001350 EBG-C1002513 EBG-C1001404 EBG-C1001816 C0837060-EBG EBG-C1001476 EBG-C1002005 EBG-C1002007 EBG-C1002017 EBG-C1001108 EBG-C1000968 EBG-C1003231 EBG-C1000969 EBG-C1001897 EBG-C1002559 EBG-C1002558 EBG-C1002564 EBG-C1002570 EBG-C1002732 EBG-C1002943 EBG-C1002976 EBG-C1002993 EBG-C1003030 EBG-C1002568 EBG-C1003019 EBG-C1002396 EBG-C1002432 EBG-C1002557 EBG-C1002565 EBG-C1004025 C0837050-EBG EBG-C1001020 EBG-C1002686 EBG-C1000971 EBG-C1000650 EBG-C1001080 EBG-C1001782 EBG-C1002605 EBG-C1001537 EBG-C1001761 EBG-C1001785 EBG-C1002033 EBG-C1002039 EBG-C1002040 EBG-C1002177 EBG-C1002627 EBG-C1001306 EBG-C1002004 EBG-C1002652 EBG-C1002035 C0917072-EBG EBG-C1000110 EBG-C1002164 EBG-C1002591 C0917044-EBG EBG-C1000059 EBG-C1000114 EBG-C1000963 EBG-C1001764 EBG-C1001797 EBG-C1002566 EBG-C1003236 EBG-C1001679 EBG-C1001758 EBG-C1001768 EBG-C1002023 EBG-C1002609 EBG-C1001422 EBG-C1001418 EBG-C1001424 EBG-C1001545 EBG-C1001770 EBG-C1002009 EBG-C1002016 EBG-C1002615 EBG-C1002025 EBG-C1001362 EBG-C1001695 EBG-C1001765 EBG-C1001779 EBG-C1002022 EBG-C1002739 EBG-C1002011 EBG-C1000079 EBG-C1000041 EBG-C1000043 EBG-C1000063 EBG-C1000355 EBG-C1001675 EBG-C1001749 EBG-C1002855 EBG-C1001403 EBG-C1001968 EBG-C1001987 EBG-C1001988 EBG-C1002613 EBG-C1001290 EBG-C1001343 EBG-C1001549 EBG-C1001783 EBG-C1002026 EBG-C1002710 EBG-C1003238 EBG-C1003223 EBG-C1001322 EBG-C1001375 EBG-C1001393 EBG-C1001407 EBG-C1001413 EBG-C1001421 EBG-C1001507 EBG-C1001511 EBG-C1001513 EBG-C1001517 EBG-C1001525 EBG-C1001526 EBG-C1001530 EBG-C1001693 EBG-C1001750 EBG-C1001772 EBG-C1001774 EBG-C1001777 EBG-C1001778 EBG-C1001781 EBG-C1001784 EBG-C1002024 EBG-C1002032 EBG-C1001278 EBG-C1001323 EBG-C1002019 EBG-C1002569 EBG-C1002610 EBG-C1002616 EBG-C1002678 EBG-C1002708 EBG-C1001015 C0914041-EBG EBG-C1001245 EBG-C1002735 EBG-C1001539 EBG-C1002881 EBG-C1002899 EBG-C1000016 EBG-C1001470 EBG-C1001498 EBG-C1001524 EBG-C1001529 EBG-C1001611 EBG-C1001798 EBG-C1001864 EBG-C1001867 EBG-C1001878 EBG-C1001883 EBG-C1000115 EBG-C1000989 EBG-C1001379 EBG-C1001979 EBG-C1002618 EBG-C1002716 EBG-C1001753 EBG-C1001548 EBG-C1001648 EB2-C1000137 EBG-C1003075 C0837037-EBG EBG-C1003065 EBG-C1000578 C0914065-EBG EBG-C1001264 EBG-C1001406 EBG-C1002913 EBG-C1001799 EBG-C1002680 EBG-C1000587 EBG-C1001224 EBG-C1002338 EBG-C1000992 EBG-C1002109 EBG-C1001806 EBG-C1002106 EBG-C1002225 EBG-C1002226 EBG-C1002227 EBG-C1002232 EBG-C1002233 EBG-C1002243 EBG-C1001821 EBG-C1000181 EBG-C1002234 EBG-C1000142 EBG-C1000279 EBG-C1002275 EBG-C1002586 EBG-C1002590 EBG-C1002750 EBG-C1001516 EBG-C1002006 EBG-C1002916 EBG-C1002027 EBG-C1002029 EBG-C1002031 EBG-C1001615 EBG-C1002188 EBG-C1002369 EBG-C1002413 EBG-C1002435 EBG-C1002436 EBG-C1002489 EBG-C1002534 EBG-C1002540 EBG-C1001366 EBG-C1000277 EBG-C1002364 EBG-C1002548 EBG-C1002571 EBG-C1002563 EBG-C1002787 EBG-C1002554 EBG-C1002555 EBG-C1002556 EBG-C1002753 EBG-C1002952 EBG-C1002964 EBG-C1002965 EBG-C1002970 EBG-C1002982 EBG-C1003018 EBG-C1003021 EBG-C1003027 EBG-C1003040 EBG-C1001383 EBG-C1001023 EBG-C1001091 EBG-C1001762 EBG-C1003486 EBG-C1003470 EBG-C1000457 EBG-C1000476 EBG-C1000424 EBG-C1000437 EBG-C1000561 EBG-C1001504 EBG-C1002497 EBG-C1003026 EBG-C1003661 EBG-C1001860 C0914014-EBG EBG-C1001790 EBG-C1000449 EBG-C1002217 EBG-C1002797 EBG-C1002399 EBG-C1002363 EBG-C1002410 EBG-C1002411 EBG-C1002419 EBG-C1002420 EBG-C1002950 C0914045-EBG EBG-C1000052 EBG-C1002267 EBG-C1002021 EBG-C1003582 EBG-C1003620 C0914086-EBG EBG-C1001368 Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772
ClassificationClass II
Reason for RecallCalibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.
Product Quantity519 units were calibrated at the service center
Recall NumberZ-1532-2013

Class II Devices Event

Event ID65188
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityWest Sacramento
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionSiemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Code InfoLot: 2013-11-13, Exp 11/13/2013.
ClassificationClass II
Reason for RecallThe product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Product Quantity683 units
Recall NumberZ-1525-2013

Class II Devices Event

Event ID65217
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApplied Medical Resources Corp
CityRancho Santa Margarita
StateCA
CountryUS
Distribution PatternWorldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
 

Associated Products

Product DescriptionApplied Medicals Epix® and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Code InfoModel Numbers C4130 and C4140. MODEL NUMBERS C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper LOT NUMBERS 1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394, 1154637, 1155135, 1155473, 1155948, 1156004, 1156010, 1156011, 1156012, 1156270, 1156360, 1156452, 1156577, 1156857, 1157218, 1157679, 1157950, 1157951, 1157952, 1157953, 1157954, 1158052, 1158131, 1158216, 1158217, 1158425, 1159491, 1160167, 1161136, 1161137, 1161398, 1161638, 1162112, 1162503, 1162504, 1162588, 1163399, 1163558, 1163559, 1163575, 1164580, 1164581, 1164582, 1164583, 1168124, 1168637, 1168638, 1169117, 1171168, 1171631, 1172170, 1172668, 1173153, 1174995, 1174996, 1176616, 1177407, 1177408, 1178109, 1180295, 1181554, 1182940, 1183774, 1184416, 1184959, 1187241, 1188110, 1188745, 1189773, 1191368, 1191809. C4140- 5mm x 45cm Epix/Direct Drive Laparoscopic Grasper 1145559, 1147851, 1147852, 1147960, 1148210, 1148211, 1149038, 1149039, 1149689, 1149936, 1150488, 1150489, 1151249, 1152594, 1153330, 1155645, 1157217, 1157949, 1158644, 1160033, 1160170, 1162111, 1167871, 1169855, 1171497, 1172009, 1173587, 1174121, 1177578, 1179347, 1180753, 1181346, 1182924, 1183769, 1184961, 1188111, 1189182 Various Kits Containing Either C4130 or C4140 1148079, 1148139, 1148145, 1148250, 1148514, 1148770, 1148780, 1149100, 1149605, 1150455, 1151831, 1153074, 1153702, 1154931, 1154997, 1155332, 1156581, 1156812, 1157090, 1158535, 1160152, 1160227, 1160388, 1161766, 1162189, 1162343, 1163348, 1163881, 1164590, 1164796, 1164831, 1165443, 1166520, 1168227, 1169190, 1169456, 1169620, 1169772, 1170151, 1170378, 1171280, 1171878, 1171879, 1172330, 1173319, 1173903, 1174093, 1175987, 1175991, 1176171, 1178210, 1178498, 1178581, 1179376, 1182679, 1182972, 1183303, 1184673, 1185599, 1185762, 1186257, 1186868, 1187082, 1188827, 1189581, 1190574, 1191055, 1193112, 1193147, 1193648, 1193688, 1194964, 1194965
ClassificationClass II
Reason for RecallApplied Medical is conducting a voluntary recall on specific lot numbers of its Epix® and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.
Product Quantity127,305 units
Recall NumberZ-1521-2013

Class II Devices Event

Event ID65283
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDental EZ Stardental Division
CityLancaster
StatePA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
 

Associated Products

Product DescriptionStarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Code InfoItem 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.
ClassificationClass II
Reason for RecallRecall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
Product Quantity3,560
Recall NumberZ-1522-2013

Class II Devices Event

Event ID65285
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Medical Optics, Inc.
CityMilpitas
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .
 

Associated Products

Product DescriptionSTAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Code InfoModel 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
ClassificationClass II
Reason for RecallUnder specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Product Quantity1,882 total all systems
Recall NumberZ-1539-2013
Product DescriptionSTAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Code InfoModel 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
ClassificationClass II
Reason for RecallUnder specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Product Quantity1,882 - total all systems
Recall NumberZ-1540-2013
Product DescriptionSTAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Code InfoModel 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
ClassificationClass II
Reason for RecallUnder specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Product Quantity1,882, total all systems
Recall NumberZ-1541-2013

Class II Devices Event

Event ID65296
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFenwal Inc
CityLake Zurich
StateIL
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionAMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Code InfoModel No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
ClassificationClass II
Reason for RecallFenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the symbols used on the label.
Product Quantity19 Cases (114 Units)
Recall NumberZ-1523-2013

Class II Drugs Event

Event ID65318
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionCefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
Code InfoLot #: DB2208, Exp 01/16
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Product Quantity297,200 vials
Recall NumberD-597-2013

Class II Devices Event

Event ID65330
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon Endo-Surgery Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia.
 

Associated Products

Product DescriptionECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¬" lock-out feature is designed to prevent a used reload from being refired.
Code InfoThe following lot numbers and associated expiration dates are affected by this recall: J4AY8Z 5/15/2013, J4C00J 6/15/2013, J4C87R 7/15/2013, J4CC1F 8/15/2013, J4CD2X 8/15/2013, J4CF3D 9/15/2013, J4CJ0E 9/15/2013, J4CJ78 9/15/2013, J4CK2P 9/15/2013, J4CM9X 10/15/2013, J4CR2H 10/15/2013, J4CT5H 11/15/2013, J4CU86 11/15/2013, J4CV1W 11/15/2013, J4CV5H 11/15/2013, K4C149 12/15/2013, K4C17W 12/15/2013, K4C33U 12/15/2013, K4C41C 12/15/2013, K4C600 1/15/2014, K4C64A 1/15/2014, 4C728 1/15/2014, K4C82K 1/15/2014, K4C88F 1/15/2014, K4C94W 1/15/2014, K4CC0L 2/15/2014, CC8L 2/15/2014, K4CD1E 2/15/2014, K4CF1P 2/15/2014, K4CF5D 2/15/2014, K4CG18 3/15/2014, K4CG4J 3/15/2014, K4CG8P 3/15/2014, K4CH44 3/15/2014, K4CK0W 3/15/2014,
ClassificationClass II
Reason for RecallEthicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Product Quantity57,540 Units
Recall NumberZ-1530-2013

Class II Devices Event

Event ID65341
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInternational Biomedical, Ltd.
CityAustin
StateTX
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionVIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).
Code InfoModel/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489
ClassificationClass II
Reason for RecallInternational Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to assure a tight seal while not allowing the component to be overtightened to the extent where an occlusion would occur.
Product Quantity7,000
Recall NumberZ-1531-2013

Class II Food Event

Event ID65351
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Importing Co, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternOne main customer, Target Corporation with 52 distribution locations. AL, AZ, CA, CO, GA, IL, IN, IA, KS, MI, MN, NY, NC, OH, OR, PA SC, TX, VA, WI.
 

Associated Products

Product DescriptionMarket Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY, May contain tree nuts, milk, wheat and eggs. Distributed by Target Corporation, Minneapolis, MN 55403.
Code Info 074X348, 092X348, 105X348, 106X348, 107X348, 108X348, 109X348, 112X348, 120X348, 121X348, 122X348.
ClassificationClass II
Reason for RecallAmerican Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts instead of , Honey Roasted Peanuts listed on the label. Butter Toffee Peanuts contain a very small amount of butter (0.5% to 1.0%) which is a milk allergen.
Product Quantity2869 cases (24 cups per case)
Recall NumberF-1529-2013

Class II Devices Event

Event ID65374
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUtah Medical Products, Inc
CityMidvale
StateUT
CountryUS
Distribution PatternWorldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.
 

Associated Products

Product DescriptionDeltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
Code InfoPart number DPT-248A, lot number 1122508.
ClassificationClass II
Reason for RecallUtah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.
Product Quantity1,800 kits
Recall NumberZ-1543-2013

Class II Devices Event

Event ID65395
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBard Peripheral Vascular Inc
CityTempe
StateAZ
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionBARD PERIPHERAL VASCULAR VACCESS® PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess® PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess® PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.
Code InfoProduct Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090
ClassificationClass II
Reason for RecallBard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.
Product Quantity415
Recall NumberZ-1533-2013

Class III Biologics Event

Event ID42768
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info2109548
ClassificationClass III
Reason for RecallBlood product was not frozen in required time, was distributed.
Product Quantity1 unit
Recall NumberB-1385-13

Class III Biologics Event

Event ID46459
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2418777
ClassificationClass III
Reason for RecallBlood products, possibly contaminated with bacteria, were distributed.
Product Quantity2
Recall NumberB-1505-13

Class III Biologics Event

Event ID52268
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Dec-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3830008531; 3830009771; 3830009865; 3830009612; 3830010411; 3830009520; 3830010295; 3830009775; 3830010581; 3830009051; 3830009695; 3830010420; 3830008640; 3830010711; 3830010383; 3830009301; 3830009844; 3830010915; 3830008657; 3830008535; 3830008540; 3830008794; 3830008643; 3830009187; 3830009876; 3830010693; 3830009853; 3830009512; 3830010602; 3830008504; 3830009036; 3830009296; 3830010414; 3830009601; 3830009899; 3830009341; 3830008775; 3830009060; 3830009772; 3830008808; 3830009792; 3830010384; 3830010204; 3830008770; 3830009037; 3830009686; 3830010360; 3830010112; 3830010254; 3830009776; 3830008664; 3830009525; 3830010065; 3830008822; 3830009025; 3830008999; 3830010416; 3830009654; 3830010449; 3830010455; 3830009032; 3830009222; 3830009568; 3830010852; 3830008621; 3830010276; 3830009152; 3830010378; 3830010819; 3830010389; 3830010215; 3830010742; 3830010895; 3830009808; 3830010727; 3830008545; 3830008982; 3830010077; 3830009529; 3830009696; 3830010072; 3830010407; 3830010745; 3830009159; 3830009579; 3830010261; 3830008551; 3830009135; 3830009193; 3830008778; 3830010330; 830010579
ClassificationClass III
Reason for RecallBlood products, collected from donors whose donor suitability was not adequately determined, were distributed.
Product Quantity92
Recall NumberB-1443-13

Class III Biologics Event

Event ID56582
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCsl Plasma Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternIllinois, North Carolina, California, Germany, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info07 GDNBPZ, 07 GDSKNV, 07 GDSNJB, 07 GDSPMR, 07 GDSPYX, 07 GDJYGX, 07 GDJYNW, 4070342125, 4070329901, 4070329359, 4070027503, 4070025276, 4070024688, 07 GDWDKZ, 07GDRMTM, 07 GDRLZW, 4070007524, 4070007092, 4070000259, 07 GDVFNF, 07 GDRNXH, 07 GDRKVD, 07 GDRJZV, 07 GDRHTD, 07 GDPFTL, 07 GDNNNR, 07 GDNMXL, 07 GDLCHV, 07 GDLBYG, 07 CRYKNF, 07 CRXNHC, 07 CRXHMK, 07 CRXHCK, 07 CRXGFD, 07 CRXFNG, 07 CRXBPF, 07CRWZZP, 07 CRWNTF, 07 CRRFTX, 4070203800, 4070202955, 4070070885, 4070070136, 4070069698, 4070068917, 4070067519, 4070066918, 4070192972, 4070192186, 4070191328, 4070190659, 4070188959, 4070187779, 4070185953, 4070184320, 4070182771, 4070181929, 4070180972, 4070177519, 4070176464, 4070175984, 4070175075, 4070073132, 4070072783, 4070048291, 4070047820, 4070047264, 4070047021, 4070046564, 4070046280, 07 GDQXRS, 07 GDQWBR, 07 GDQTXX, 07 GDKCBH, 07 GDJZVZ, 07 GDJTNZ, 07 GDJTFJ, 07 GDJSRW, 07 GDDSBN, 07 GDDRTT, 07 GDDQFW, 07 GDDNQW, 07 GDDBTZ, 07 GDDBPD, 07 CRXXKB, 07 CRXYXZ, 07 CRXYKJ, 07 CRXWGD, 07CRXVXZ, 07 CRPZQW, 07 CRPYYX, 07 CRPYQV, 07 CRPXNG, 07 CRPXCW, 07 CRPVFQ, 07 CRPTVK, 07 CRYMLN, 07 CRYHXH, 07 CRWMRY, 07 CRWJVY, 07 CRWJKN, 07 CRWHMQ, 07 CRSXKL, 07 CRSWXR, 07 CRSWHT, 07 CRSVGR, 07 CRRDVL, 07 CRNZNC, 07 CRNXXZ, 07 CRLVRJ, 07 CRPFDC, 4070101194, 4070100488, 4070099697, 4070099207, 4070098529, 4070098072, 4070097359, 4070096889, 4070087737, 4070087113, 4070086320, 4070085713, 4070084993, 4070084376, 4070083704, 4070083198, 4070082538, 4070082035, 4070081244, 4070080942, 4070052824, 4070051694, 4070051124, 07 GDVLJR, 07 GDTFNG, 07 GDRJVB, 07 GDJWJR, 07 GDVFVS, 07 GDVDJP, 07 GDVBKY, 07GDTZLM, 07 GDRKWM, 07 GDJYPK, 07 GDJYHZ, 07 GDJXZF, 07 GDJXVV, 07 GDJXQD, 07 GDJXKT, 07 GDJXBJ, 07 GDJWMH, 07 GDFZMP, 07 GDFZFD, 07 GDFZBP, 07 GDFYRR, 07 GDFYKH, 07 GDFXZF, 07 GDFXLG, 07 GDFWTM, 07 CRSGMK, 07 CRSGGM, 07 CRSDSF, 07 CRSDNL, 07 CRSDLG, 07 CRSBSN, 07 CRSBDP, 07 CRSGDK, 07 CRSFXB, 07 CRSFSD, 07 CRSFFM, 07 CRRZQY, 07 CRRZLR, 07 CRQHNF, 07 CRQHGD, 07 CRQHDW, 07 CRQGLZ, 07 CRQGHF, 07 CRQGFG, 07 CRQFQG, 07 CRQFNP, 07 CRQFKT, 07 CRQFFM, 07 CRJBZR, 07 CRJBJJ, 07 CRJHNP, 07 CRJHKX, 07 CRWNTL, 4070047099, 4070046652, 4070046431, 07 CRNBPV, 07 CRNBPB, 07 CRNBDV, 07 CRNBBN, 07 CRMZXS, 07 CRMZSL, 07 CRMZJN, 07 CRMYXW, 07 CRMYJS, 07 CRMYGM, 07 GDNQNK, 07 GDMJYT, 07 GDMWKG, 07 GDMTYG, 07 GDMTTJ, 07 GDDSGP, 07 GDDQDV, 07 GDDNGD, 07 GDDLKG, 07 CRXWDH, 07 CRXVTV, 07 CRXTDR, 07 CRXSLJ, 07 CRXPZG, 07 CRVRNV, 07 CRVQML, 07 CRVQBF, 07 CRRMXZ, 07 CRRLPD, 07 CRRLJJ, 07 CRPFPV, 07 CRPDKM, 07 CRPCMJ, 07 CRXLYY, 07 CRXJQC, 07 CRXGKH, 07 CRXFRC, 07 CRXFDD, 07 CRXDMQ, 07 CRXCWL, 07 CRXCFR, 07 CRWLLP, 07 CRWKND, 07 CRWKGB, 07 CRWJHQ, 07 CRWHYX
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Product Quantity236 units
Recall NumberB-1399-13

Class III Biologics Event

Event ID64399
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasma Biological Services
CityAsheville
StateNC
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info12ANCE5442;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm inspection was not documented, was distributed.
Product Quantity1
Recall NumberB-1182-13

Class III Biologics Event

Event ID64521
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityLubbock
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionPlasma Frozen
Code InfoW041513000604*, W041513000605Y, W041513000613Y, W041513000615U
ClassificationClass III
Reason for RecallBlood products, collected from donors whose body temperatures were determined incorrectly, were distributed.
Product Quantity4 units
Recall NumberB-1486-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041513000604*, W041513000606W, W041513000609Q, W041513000612*, W041513000613Y, W0415130006015, W0415130006023, W041513000605Y, W041513000614W, W041513000615U
ClassificationClass III
Reason for RecallBlood products, collected from donors whose body temperatures were determined incorrectly, were distributed.
Product Quantity10 units
Recall NumberB-1487-13

Class III Biologics Event

Event ID65044
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFenwal Inc
CityLake Zurich
StateIL
CountryUS
Distribution PatternUS (CA, OR, OH, MI)
 

Associated Products

Product DescriptionAnticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584
Code InfoFM13A15027
ClassificationClass III
Reason for RecallBLOOD-PACK Units in which the platelet container is incorrectly labeled as "AS-1 Red Blood Cell Adenine-Saline added", were distributed.
Product Quantity16,740 units
Recall NumberB-1669-13

Class III Drugs Event

Event ID65050
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionAmoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Code Infoa) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.
ClassificationClass III
Reason for RecallDiscoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Product Quantity758,554 bottles
Recall NumberD-598-2013

Class III Food Event

Event ID65201
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public email
Recalling FirmBerkshire Cheese LLC
CityGreat Barrington
StateMA
CountryUS
Distribution PatternMA
 

Associated Products

Product DescriptionBerkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic
Code InfoBatch HZ
ClassificationClass III
Reason for RecallE. Coli contamination (non pathogenic)
Product Quantity149 lbs
Recall NumberF-1530-2013

Class III Drugs Event

Event ID65334
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionFentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Code InfoLot #: Patch 453658; Carton 453658A, Exp 09/13
ClassificationClass III
Reason for RecallFailed Impurities/Degradation Specifications
Product Quantity98,952 boxes
Recall NumberD-599-2013

Mixed Classification Biologics Event

Event ID49299
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFL, MA, TN, NJ, KY, Puerto Rico
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2224422; 2224424; 2224425; 2224427; 2225134; 2225137; 2225139; 2225174; 2227106; 2227116; 2227127; 2227152; 2228116; 2228150; 2228152; 2228239; 2228255; 2228256; 2228285; 2228342; 2228349; 2228352; 2228364; 2228366; 2228367; 2228377; 2228381; 2228384; 2228387; 2229530; 2229532; 2229535; 2229552; 2229554; 2229559; 2229564; 2229568; 2229582; 2230415; 2230423; 2230437; 2230439; 2230476; 2230477; 2230479; 2230480; 2230485; 2230487; 2230490; 2230578; 2230582; 2230590; 2230595; 2230597; 2230599; 2230600; 2230656; 2230725; 2230727; 2230731; 2230765; 2230776; 2230896; 2231207; 2231211; 2231297; 2231301; 2231322; 2231327; 2231329; 2231334; 2231358; 2231376; 2231377; 2231382; 2231384; 2231388; 2231394; 2231396; 2231397; 2231407; 2231411; 2231413; 2231417; 2231420; 2231422; 2231423; 2231424; 2231425; 2231427; 2231429; 2231431; 2231434; 2231436; 2231440; 2231441; 2231442; 2231444; 2231446; 2231447; 2231448; 2231450; 2232113; 2232781; 2232801; 2232835; 2232837; 2232841; 2232843; 2232846; 2232853; 2232863; 2232868; 2232883; 2232885; 2232888; 2232892; 2232900; 2232904; 2233005; 2233007; 2233054; 2233060; 2233061; 8814339; 88114344; W038608280167; W038608280172; W038608280175; W038608280177; W038608280182; W038608280214; W038608280218; W038608280221; W038608280241; W038608280247; W038608280253; W038608280255; W038608280256; W038608280257; W038608280261; W038608280262; W038608280265; W038608280266; W038608280268; W038608280270; W038608280271; W038608280273; W038608280276; W038608280338; W038608280340; W038608280342; W038608280388; W038608280390; W038608280391; W038608280393; W038608280402; W038608280403; W038608280415; W038608280418; W038608280421; W038608280450; W038608280455; W038608280457; W038608280462; W038608280482; W038608280566; W038608280568; W038608280578; W038608280582; W038608280667; W038608280668; W038608280759; W038608280760; W038608280762; W038608280765; W038608280784; W038608280786; W038608280792; W038608280859; W038608280861; W038608280862; W038608280866; W038608280913; W038608281321; W038608281323; W038608281327; W038608281329; W038608281330; W038608281331; W038608281335; W038608281337; W038608281425; W038608281625; W038608281626; W038608281629; W038608281639; W038608281644; W038608281650; W038608281655; W038608281661; W038608281666; W038608281710; W038608281757; W038608281759; W038608281795; W038608281854; W038608281876; W038608281905; W038608281910; W038608281916; W038608281919; W038608281921; W038608282226; W038608282250; W038608282252; W038608282254; W038608282259; W038608282359; W038608282361; W038608282619; W038608282621; W038608282624; W038608282627; W038608282661; W038608282663; W038608282665; W038608282848; W038608282851; W038608282854; W038608282874; W038608282877; W038608880849; W038608880851; W038608880862; W038608881801; W038608881809; W038608881810; W038608881813; W038608881815; W038608881817; W038608881822.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity242 units
Recall NumberB-1415-13
Product DescriptionFresh Frozen Plasma
Code Info2224422; 2227113; 2227117; 2227152; 2228255; 2228256; 2228340; 2228345; 2228349; 2229530; 2229532; 2229533; 2229554; 2229579; 2229582; 2230411; 2230433; 2230656; 2230777; 2230779; 2230943; 2231222; 2231297; 2231314; 2231318; 2231320; 2231331; 2231334; 2232781; 2232789; 2232791; 2232793; 2232835; 2232837; 2232842; 2232843; 2232846; 2232853; 2232861; 2232868; 2232876; 2232893; 2232900; 2232909; 8814339; 8814344; W038608280210; W038608280338; W038608280340; W038608280342; W038608280365; W038608280405; W038608280441; W038608280450; W038608280455; W038608280457; W038608280482; W038608280566; W038608280568; W038608280573; W038608280582; W038608280586; W038608280762; W038608280765; W038608280866; W038608280913; W038608281335; W038608281620; W038608281661; W038608281666; W038608281670; W038608281698; W038608281701; W038608281703; W038608281710; W038608281757; W038608281795; W038608281910; W038608281916; W038608282225; W038608282248; W038608282617; W038608282629; W038608282661; W038608282665; W038608880862; W038608881040; W038608881044; W038608881813; W038608881815; W038608881817; W038608881822.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity92 units
Recall NumberB-1416-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info2224421; 2227153; 2228344; 2228348; 2229556; 2230421; 2230651; 2231443; 2232849; 2232854; 2232887; 2232910; W038608280358; W038608280420; W038608280456; W038608280581; W038608280672; W038608281606; W038608281612; W038608281891; W038608281922; W038608282360; W038608282666; W038608880242; W038608881051.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity25 units
Recall NumberB-1417-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2224423; 2225130; 2225141; 2227075; 2227109; 2227113; 2227117; 2227120; 2227122; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228139; 2228145; 2228262; 2228277; 2228340; 2228345; 2228351; 2228360; 2228376; 2228389; 2229533; 2229570; 2229572; 2229574; 2229579; 2229584; 2230026; 2230411; 2230431; 2230433; 2230440; 2230653; 2230661; 2230664; 2230723; 2230729; 2230733; 2230769; 2230772; 2230773; 2230777; 2230779; 2230943; 2230950; 2231218; 2231222; 2231299; 2231303; 2231304; 2231310; 2231312; 2231314; 2231315; 2231316; 2231318; 2231320; 2231331; 2231335; 2231342; 2231347; 2231354; 2231359; 2231401; 2232373; 2232774; 2232779; 2232786; 2232788; 2232789; 2232791; 2232793; 2232796; 2232798; 2232839; 2232842; 2232858; 2232861; 2232865; 2232870; 2232876; 2232878; 2232880; 2232893; 2232906; 2232909; W038608280184; W038608280210; W038608280242; W038608280251; W038608280336; W038608280350; W038608280355; W038608280365; W038608280405; W038608280406; W038608280408; W038608280409; W038608280412; W038608280413; W038608280441; W038608280454; W038608280564; W038608280571; W038608280573; W038608280579; W038608280583; W038608280586; W038608280589; W038608280780; W038608281602; W038608281620; W038608281636; W038608281656; W038608281657; W038608281670; W038608281698; W038608281701; W038608281703; W038608281800; W038608281801; W038608281862; W038608281875; W038608281881; W038608282225; W038608282247; W038608282248; W038608282876; W038608282878; W038608282887; W038608880850; W038608881040; W038608881044.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity140
Recall NumberB-1418-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info8814517; 8814559; W038608880648.
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-1419-13
Product DescriptionFresh Frozen Plasma (Apheresis)
Code Info8814559; W038608880648.
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-1420-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2224423; 2224424; 2224425; 2224427;2225130; 2225134; 2225137; 2225139; 2225174; 2227075; 2227106; 2227109; 2227116; 2227120; 2227122; 2227127; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228116; 2228139; 2228145; 2228150; 2228152; 2228239; 2228262; 2228277; 2228285; 2228342; 2228351; 2228352; 2228360; 2228364; 2228366; 2228367; 2228376; 2228377; 2228381; 2228384; 2228387; 2228389; 2229535; 2229552; 2229559; 2229564; 2229568; 2229570; 2229572; 2229574; 2229584; 2230026; 2230415; 2230423; 2230431; 2230437; 2230439; 2230440; 2230476; 2230477; 2230480; 2230485; 2230490; 2230578; 2230582; 2230590; 2230595; 2230597; 2230599; 2230600; 2230653; 2230661; 2230664; 2230723; 2230725; 2230727; 2230729; 2230731; 2230733; 2230765; 2230769; 2230772; 2230773; 2230776; 2230896; 2230950; 2231207; 2231211; 2231218; 2231299; 2231301; 2231303; 2231304; 2231310; 2231312; 2231315; 2231316; 2231322; 2231327; 2231329; 2231335; 2231342; 2231347; 2231354; 2231358; 2231359; 2231376; 2231377; 2231382; 2231384; 2231388; 2231394; 2231396; 2231397; 2231401; 2231407; 2231411; 2231413; 2231417; 2231420; 2231422; 2231423; 2231424; 2231425; 2231427; 2231429; 2231431; 2231434; 2231436; 2231440; 2231441; 2231442; 2231444; 2231446; 2231447; 2231448; 2231450; 2232113; 2232774; 2232779; 2232786; 2232788; 2232796; 2232798; 2232801; 2232839; 2232841; 2232858; 2232863; 2232865; 2232870; 2232878; 2232880; 2232883; 2232885; 2232888; 2232892; 2232904; 2232906; 2233005; 2233007; 2233054; 2233060; 2233061; W038608280167; W038608280172; W038608280175; W038608280177; W038608280182; W038608280184; W038608280214; W038608280218; W038608280221; W038608280241; W038608280242; W038608280247; W038608280251; W038608280253; W038608280255; W038608280256; W038608280257; W038608280261; W038608280262; W038608280265; W038608280266; W038608280268; W038608280270; W038608280271; W038608280273; W038608280276; W038608280336; W038608280350; W038608280355; W038608280388; W038608280390; W038608280391; W038608280393; W038608280402; W038608280403; W038608280406; W038608280408; W038608280409; W038608280412; W038608280413; W038608280415; W038608280418; W038608280421; W038608280454; W038608280462; W038608280564; W038608280571; W038608280578; W038608280579; W038608280583; W038608280589; W038608280667; W038608280668; W038608280759; W038608280760; W038608280780; W038608280784; W038608280786; W038608280792; W038608280859; W038608280861; W038608280862; W038608281321; W038608281323; W038608281327; W038608281329; W038608281330; W038608281331; W038608281337; W038608281425; W038608281602; W038608281625; W038608281626; W038608281629; W038608281636; W038608281639; W038608281644; W038608281650; W038608281655; W038608281656; W038608281657; W038608281800; W038608281801; W038608282247; W038608282250; W038608282252; W038608282254; W038608282259; W038608282359; W038608282361; W038608880849; W038608880850; W038608880851.
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity262 units
Recall NumberB-1421-13

Mixed Classification Biologics Event

Event ID57149
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Sep-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNew York Blood Center, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternFrance, UK, NY, NJ, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW047010307591; W047009246899; W047009231214; W047010170102; W047010246859
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity5 units
Recall NumberB-1338-13
Product DescriptionRed Blood Cells
Code InfoW047010134887; W047009160659; W047008272554; 5648436
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity4 units
Recall NumberB-1339-13
Product DescriptionFresh Frozen Plasma
Code Info5648436
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity1 unit
Recall NumberB-1340-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW047009231214; W047009160659; W047008272554; W047010170102
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity4 units
Recall NumberB-1341-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW047010134887; W047009246899; W047010246859; W047010307591
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity4 units
Recall NumberB-1342-13

Mixed Classification Biologics Event

Event ID64591
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMercy Hospital St Louis
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri; California
 

Associated Products

Product DescriptionWhole Blood Leukocytes Reduced
Code InfoW069613000067;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1478-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW069613000067;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1479-13
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