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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Class I Drugs Event

Event ID63818
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmVintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
CityHuntsville
StateAL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionHydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
Code InfoLot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13
ClassificationClass I
Reason for RecallSuperpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Product Quantity897,379 bottles
Recall NumberD-138-2013

Class I Food Event

Event ID63996
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmJerusalem Manufacturing Natural Foods & Wholesalers, Inc.
CityDearborn
StateMI
CountryUS
Distribution PatternMI Only (Dexter and Clinton Twp)
 

Associated Products

Product DescriptionKinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case
Code InfoProduct code 620133006009 and lot BB2013DE13
ClassificationClass I
Reason for RecallKinnikinnick Foods Inc., a Canadian manufacturer notifed Jerusalem Manufacturing Natural Food and Wholesalers, Inc. in Dearborn, MI to recall the Kinnikinnick Foods Brand Frozen Pies, 290g/10 ounces. 2 crusts per box, 6 boxes per case due to EGG not declared on the label.
Product Quantity80 cs
Recall NumberF-0948-2013

Class I Food Event

Event ID64009
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 FirmGilster-Mary Lee Corp.
CityChester
StateIL
CountryUS
Distribution PatternDistribution made to VA, KY and TN.
 

Associated Products

Product DescriptionFood Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL.
Code InfoNOV 28 13 DO2, use by 11/28/2013
ClassificationClass I
Reason for RecallThe product contains walnuts and it was packaged in the wrong carton. Due to the mis-packaging the ingredient label does not have walnuts listed.
Product Quantity25/12/21.5-oz carton cases
Recall NumberF-0942-2013

Class I Food Event

Event ID64058
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnified Grocers Inc.
CityCity Of Commerce
StateCA
CountryUS
Distribution PatternWA, OR
 

Associated Products

Product DescriptionKinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600.
Code InfoLot code: BB2013DE12
ClassificationClass I
Reason for RecallUnified Grocers is recalling Kinnikinnick Pie Crust because it contains undeclared egg allergen.
Product Quantity5 cases (30 units)
Recall NumberF-0949-2013

Class I Food Event

Event ID64059
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKeHE/Tree of life Bloomington
CityBloomington
StateIN
CountryUS
Distribution PatternMN and PA
 

Associated Products

Product DescriptionKinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9
Code InfoBB2013DE13
ClassificationClass I
Reason for RecallKinnikinnick Foods, Inc in Edmonton, Alberta Canada indicated that KeHE Distributors in Bloomington, IN had received pie crusts in association with their recall/allergy alert issued 12/28-29/2012
Product Quantity5 cases/6 packages per case
Recall NumberF-0943-2013

Class I Food Event

Event ID64080
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmJiffy Food Service, LLC
CityChelsea
StateMI
CountryUS
Distribution PatternNationwide including Arizona, California, Colorado, Connecicut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, Missouri, Montana, New England, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virgina and Wisconsin.
 

Associated Products

Product DescriptionSpice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188.
Code InfoUPC Code 84670200985 Manufacturing Date Codes (printed on the inside seam/gusset of the bag): 08/01/2012, 08/23/2012, 10/03/2012, 11/18/2012, 11/19/2012.
ClassificationClass I
Reason for RecallUndeclared Allergen (Milk). Firm initiated a voluntary recall of their 25 lb. and 50 lb. bags of Spice Cake Mix that had been distributed since August 2012 due to an undeclared allergen, milk. The Spice Cake Mix is manufactured for correctional facilities/institutions only.
Product Quantity7,422 bags (total 25 lb. and 50 lb. combined)
Recall NumberF-0941-2013

Class I Food Event

Event ID64086
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmIsland Delights, Inc.
CitySeville
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.
 

Associated Products

Product DescriptionIsland Delights Coconut Haystack Candy Maple Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***NATURAL MAPLE FLAVOR***Island Delights, Inc. Seville, OH 44273"
Code Info2 oz, Lot #13410400.02, UPC Code 0 19694 19020 1 4 oz, Lot #13410400.04, UPC Code 0 19694 19040 9 8 oz, Lot #13410400.08, UPC Code 0 19694 19080 5 2 lb, Lot #13410402.00, no bar code
ClassificationClass I
Reason for RecallDuring a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity45/2 oz bags, 207/4 oz bags, 50/8 oz bags & 13/2 lb bags = 315 BAGS
Recall NumberF-0944-2013
Product DescriptionIsland Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL ALMOND FLAVOR***Island Delights, Inc., Seville, OH 44273"
Code Info2 oz, Lot #13413100.02, UPC Code 0 19694 71020 1 4 oz, Lot #13413100.04, UPC Code 0 19694 71040 9 8 oz, Lot #13413100.08, UPC Code 0 19694 71080 5 2 lb, Lot #13413100.00, no bar code
ClassificationClass I
Reason for RecallDuring a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity12/2 oz bags, 26/4 oz bags, 13/8 oz bags & 2/2 lb bags
Recall NumberF-0945-2013
Product DescriptionIsland Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc. Seville, OH 44273"
Code Info2 oz, Lot #13411300.02, UPC Code 0 19694 60020 5 4 oz, Lot #13411300.04, UPC Code 0 19694 60040 3 8 oz, Lot #13411300.08, UPC Code 0 19694 60080 9
ClassificationClass I
Reason for RecallDuring a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity24/4 oz bags & 38/8 oz bags = 62 bags
Recall NumberF-0946-2013
Product DescriptionIsland Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc., Seville, OH 44273"
Code Info2 oz, Lot #13413000.02, UPC Code 0 19694 70020 2 4 oz, Lot #13413000.04, UPC Code 0 19694 70040 0 8 oz, Lot #13413000.08, UPC Code 0 19694 70080 6 2 lb, Lot #13413002.00, no bar code
ClassificationClass I
Reason for RecallDuring a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity1/2 oz bag, 4/4oz bags, 5/8 oz bags = 10 bags
Recall NumberF-0947-2013

Class I Devices Event

Event ID64117
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHamilton Medical Inc
CityReno
StateNV
CountryUS
Distribution PatternUS Nationwide Distribution including the country of Switzerland.
 

Associated Products

Product DescriptionHAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Code InfoSoftware Versions 1.1.2 and below; Part numbers 161005, 161006.
ClassificationClass I
Reason for RecallAnalysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
Product Quantity97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Recall NumberZ-0741-2013

Class I Food Event

Event ID64138
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKnotts Wholesale Foods Inc
CityParis
StateTN
CountryUS
Distribution PatternTN, KY
 

Associated Products

Product DescriptionKnott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE 38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326
Code Infoall date codes up to and including 01/29
ClassificationClass I
Reason for RecallSample collected by State of Tennessee Department of Agriculture was found to contain Listeria Monocytogenes
Product Quantity461 units
Recall NumberF-0961-2013

Class I Food Event

Event ID64153
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBelmont Confections Inc
CityYoungstown
StateOH
CountryUS
Distribution PatternProduct was shipped to the following state: Texas
 

Associated Products

Product DescriptionDYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Code InfoDymatize Nutrition Elite Gourmet Cookies & Cream 1.5oz (42.5g), UPC Code, 705016993147, Lot # 12200A, Best By Date SEP 2013, Lot # 12249A, Best By Date NOV 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Cookies & Cream 3oz (85g), UPC Code, 705016993000, Lot #, 12072A, Best By Date MAY 2013, Lot # 12200A, Best By Date SEP 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014.
ClassificationClass I
Reason for RecallBelmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.
Product Quantity195,552/3 oz bars & 73,296/1.5 oz bars
Recall NumberF-0963-2013
Product DescriptionDYMATIZE NUTRITION ELITE Gourmet Fudge Brownie 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Code InfoDymatize Nutrition Elite Gourmet Fudge Brownie 1.5oz (42.5g), UPC Code, 705016993130, Lot #, 12199A, Best By Date SEP 2013, Lot # 12244A, Best By Date OCT 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Fudge Brownie 3oz (85g), UPC Code, 705016993079, Lot #, 12084A, Best By Date MAY 2013, Lot # 12199A, Best By Date SEP 2013, Lot # 12205A, Best By Date SEP 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014.
ClassificationClass I
Reason for RecallBelmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.
Product Quantity152,280/3 oz bars & 67,536/1,5 oz bars
Recall NumberF-0964-2013

Class I Food Event

Event ID64184
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmUnited Natural Foods, Inc. - Greenwood
CityGreenwood
StateIN
CountryUS
Distribution PatternCustomers are retail locations in 6 states: Illinois, Indiana, Kentucky, Michigan, Missouri, and Ohio.
 

Associated Products

Product DescriptionKinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9
Code InfoExpiration date 2013-12-11
ClassificationClass I
Reason for RecallKinnikinnick Foods, Inc. in Edmonton, Alberta Canada indicated that United Natural Foods Inc. distributors received pie crusts in association with their expanded recall/allergy alert issued 01/17/13.
Product Quantity28 cases/6 packages per case
Recall NumberF-0960-2013

Class II Biologics Event

Event ID39108
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoKN07457
ClassificationClass II
Reason for RecallBlood product, collected from a donor who disclosed taking a daily dose of Aspirin , was distributed.
Product Quantity1 Unit
Recall NumberB-0486-13

Class II Biologics Event

Event ID39986
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Apr-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoT23108
ClassificationClass II
Reason for RecallBlood product, manufactured from an overweight whole blood unit, was distributed.
Product Quantity1 Unit
Recall NumberB-0495-13

Class II Biologics Event

Event ID40385
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoY42952
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 Unit
Recall NumberB-0496-13

Class II Biologics Event

Event ID41456
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoC74031
ClassificationClass II
Reason for RecallBlood product, which tested as CMV positive but labeled as CMV negative, was distributed.
Product Quantity1 Unit
Recall NumberB-0492-13

Class II Biologics Event

Event ID41903
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoG177400
ClassificationClass II
Reason for RecallBlood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
Product Quantity1 component
Recall NumberB-0441-13

Class II Biologics Event

Event ID44134
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmUniversity of Texas Medical Branch at Galveston (The)
CityGalveston
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code Info4045540
ClassificationClass II
Reason for RecallBlood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. .
Product Quantity1 unit
Recall NumberB-0437-13

Class II Biologics Event

Event ID45117
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info011LT11137, 011LT11139 (2 units), 011LT11140, 011LT11141 (2 units), 011LT11142, 011LT11143 (2 units), 011LT11145, 011LT11146 (2 units), 011LT11148
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity13 units
Recall NumberB-0251-13

Class II Biologics Event

Event ID47139
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas; Missouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045007912369A; W045007912369B
ClassificationClass II
Reason for RecallBlood products, with positive bacterial detection testing, were distributed.
Product Quantity2 Units
Recall NumberB-0440-13

Class II Biologics Event

Event ID47621
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionPlasma Frozen
Code Info011FL56125
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0250-13

Class II Biologics Event

Event ID47985
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri; Kansas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW045006108058;W045006108058
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2 Units
Recall NumberB-0430-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW045007010581
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0431-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Code InfoW045007001094;W045007001094
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2 Units
Recall NumberB-0432-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045007142019
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0433-13
Product DescriptionFresh Frozen Plasma
Code InfoW045007010581
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0434-13

Class II Biologics Event

Event ID48835
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Systems, Inc.
CityEl Paso
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW04110800723900 (2 units)
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity2 units
Recall NumberB-0252-13

Class II Biologics Event

Event ID49703
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141608213448
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 component
Recall NumberB-0487-13

Class II Biologics Event

Event ID49719
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington.
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW141608630171.
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 component
Recall NumberB-0490-13

Class II Biologics Event

Event ID49996
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDCI Biologicals Bryan LLC
CityBryan
StateTX
CountryUS
Distribution PatternUK
 

Associated Products

Product DescriptionSource Plasma
Code InfoBY0261044, BY0261311, BY0261769, BY0261701
ClassificationClass II
Reason for RecallBlood products, which were not quarantined after receiving post donation information regarding an undocumented piercing, were distributed.
Product Quantity4 units
Recall NumberB-0327-13

Class II Biologics Event

Event ID50295
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternKS, MO, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045008003256, W045008057390
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity2 units
Recall NumberB-0331-13
Product DescriptionFresh Frozen Plasma
Code InfoW045008003256
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity1 unit
Recall NumberB-0332-13
Product DescriptionRecovered Plasma
Code InfoW045008057390
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity1 unit
Recall NumberB-0333-13

Class II Biologics Event

Event ID52279
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3330029477, 3330027679, 3330027202, 3330025120, 3330024506, 3330024164, 3330023581, 3330023226, 3330022681, 3330022333, 3330021059, 3330020730, 3330020209, 3330019963, 3330019508, 3330019196, 3330018730, 3330018444, 3330018035, 3330017783, 3330030309, 3330018282, 3330018712, 3330019199, 3330025765, 3330026011, 3330024976, 3330024363, 3330024052, 3330023419, 3330023101, 3330022517, 3330022195, 3330021609, 3330021307, 3330020758, 3330020486, 3330019998, 3330019726, 3330019222, 3330018765, 3330018494, 3330018062, 3330017810, 3330026718, 3330026182, 3330024953, 3330023960, 3330023396, 3330022135, 3330021580, 3330021215, 3330020676, 3330020241, 3330019793, 3330018720, 3330018265, 3330018374, 3330018793, 3330019188, 3330017772, 3330018034, 3330019059, 3330019369, 3330019837, 3330020033, 3330020587, 3330020917, 3330021424, 3330021787, 3330022332, 3330022513, 3330023224, 3330024160, 3330024499, 3330025116, 3330025523, 3330026164, 3330026563, 3330028333, 3330028819, 3330029476, 3330029945, 3330030611, 3330031014, 3330027096, 3330027533, 3330028409, 3330029375, 3330026417, 3330026023, 3330025354, 3330023120, 3330022530, 3330022215, 3330021616, 3330020481, 3330020323, 3330019728, 3330019417, 3330018956, 3330018260, 3330017828, 3330027099, 3330027829, 3330029433, 3330018381, 3330021722, 3330023176, 3330018778, 3330019135, 3330022272, 3330022619, 3330023495, 3330024089, 3330025041, 3330025479, 3330028782, 3330018441, 3330018863, 3330019904, 3330020850, 3330021260, 3330023485, 3330023882, 3330027594, 3330028065, 3330028691, 3330017850, 3330021000, 3330022117, 3330022238, 3330023010, 3330023163, 3330029378, 3330017844, 3330018092, 3330019868, 3330020167, 3330023142, 3330023459, 3330027176, 3330030150, 3330017963, 3330018244, 3330018795, 3330018946, 3330018414, 3330018970, 3330019469, 3330019720, 3330020258, 3330020551, 3330021338, 3330021896, 3330022285, 3330027030, 3330027659, 3330030365, 3330030962, 3330027788, 3330029972, 3330027293, 3330029049, 3330018504, 3330018775, 3330022766, 3330029401, 3330018790, 3330018404, 3330017858, 3330018129, 3330026309, 3330028363, 3330028238, 3330026648, 3330027376
ClassificationClass II
Reason for RecallBlood products, collected from donors who did not have a complete physical examination, were distributed.
Product Quantity177 units
Recall NumberB-0300-13

Class II Biologics Event

Event ID53065
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jul-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityLogan
StateUT
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info0660055061, 0660054502, 0660054240, 0660049416, 0660048942, 0660048564, 0660047987, 0660047710, 0660047085, 0660046742, 0660046235, 0660045960, 0660045588, 0660045338, 0660044759, 0660044393, 0660043882, 0660043549, 0660041282, 0660040566, 0660040325, 0660039692, 0660039074, 0660038222, 0660037800, 0660037736, 0660037193, 0660036536, 0660036319, 0660035739, 0660035564, 0660035055, 0660034745, 0660034036, 0660033826, 0660033293, 0660032698, 0660032218, 0660031927, 0660031452, 0660031150
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of incarceration, were distributed.
Product Quantity41 units
Recall NumberB-0339-13

Class II Biologics Event

Event ID54960
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCSL Plasma, Inc.
CityOklahoma City
StateOK
CountryUS
Distribution PatternIL, Germany, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4220524051, 4220494958, 4220494293, 4220491853, 4220489422, 4220487129, 4220486475, 4220484309, 4220483659, 4220481231, 4220480399, 4220478728, 4220477840, 4220475733, 4220474704, 4220472654, 4220471314, 4220444494, 4220443659, 4220441380, 4220438250, 4220435898, 4220434960, 4220432970, 4220432061, 4220430182, 4220429369, 4220427170, 4220424871, 4220424060, 4220422093, 4220421302, 4220419533, 4220418804, 4220417064, 4220416438, 4220414286, 4220412438, 4220411684, 4220409165, 4220408380, 4220406850, 4220361334, 4220360279, 22BJSXJX, 22BJSWSB, 22BJSTQH, 22BJSTDM, 22BJPWZT, 22BJRVCR, 22GBTRMZ, 22GBTRDV, 22GBTQGW, 22GBTPXV, 22GBTHMR, 22GBQYBT, 22GBQXQJ, 22GBQWVZ, 22GBQWKK, 22GBQTHM, 22GBQSVT, 22GBRFGD, 22GBRDVY, 22GBRCTD, 22GBRBZX, 22GBKVGJ, 22GBKTPV, 22GBKRPK, 22GBKQJH, 22GBKPJB, 22GBKLYT, 22GBKKZZ, 22GBKKKT, 22GBKJNX, 22GBKGXH, 22GBKFTG, 22GBKFGB, 22GBKCSG, 22GBJYQW, 22GBJXZM, 22GBBNVK, 22GBBMZC, 22GBBFQK, 22GBBKLJ, 22GBBHNR, 22GBBDZC, 22GBBBKB, 22BJWWZT, 22BJVZWT, 22BJVWJY, 22BJVVVQ, 22BJVVFN, 22BJVTQK, 22BJTSKT, 22BJTRXW, 22BJTRJX, 22BJTPKW, 22BJTPCW, 22BJSPSF, 22BJSNRD, 22BJQLPC, 22BJQHZX, 22BJQHHQ, 22BJQFSR, 22BJQFBG, 22BJQDDC, 22BJQCNX, 22BJQBPG, 22HJQYDG, 22HJQWZH
ClassificationClass II
Reason for RecallBlood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Product Quantity110 units
Recall NumberB-0284-13

Class II Biologics Event

Event ID57284
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info0750007513 ;0750007843 ;0750008087 ;0750008301 ; 0750008547 ;0750000881 ; 0750009025 ;0750009484 ; 0750009742 ;0750010030 ;0750010314 ;0750010775 ; 0750011032 ;0750011312 ;0750011547 ;0750011877 ; 0750012029 ;0750012316 ;0750012601 ;0750012935 ; 0750013195 ;0750013556 ;0750013768 ;0750014035 ; 0750014273 ;0750014558 ;0750014804 ;0750015046 ; 0750021576 ;0750021705 ;0750022226 ;0750022421 ; 0750022825 ;0750023063 ;0750023388 ;0750023759 ; 0750024210 ;0750024500 ;0750024981 ;0750025221 ; 0750025577 ;0750026013 ;0750026548 ; 0750027012 ;0750027282 ;0750028041 ;0750028455 ; 0750028661 ;0750029157 ;0750029509 ;0750029982 ; 0750030304 ;0750030650 ;0750031601 ;0750032227 0750000010; 0750000072 ; 0750000121 ; 0750000232 ; 0750000319 ;0750000474;0750000547 ;0750000727 ; 0750000887 ;0750001012 ;0750001234 ;0750001493 ; 0750001693 ;0750001795 ;0750002091 ;0750002225 ; 0750002468 ;07500024601 ;0750002906 ;0750003104 ; 0750003318 ;0750003540 ;0750003839 ;0750004019 ; 0750004298 ;0750004489 ;0750004788 ;0750005077 ; 0750005322 ;0750005627 ;0750005850 ;0750006181 ; 0750006407; 075 0006736 ;0750007002 ;0750007335
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity91
Recall NumberB-0497-13

Class II Biologics Event

Event ID58605
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCoffee Memorial Blood Center, Inc.
CityAmarillo
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code InfoW067311002332A; W067311002638A; W067311002346A; W067311002603; W067311002663; W067311002665; W067311002723; W067311002327; W067311002326; W067311002329; W067311002722A; 067311002722B; W067311002545; W067311002332B;W067311002638A; W0673110026142A; W0673110026142B
ClassificationClass II
Reason for RecallBlood products, for which the sterility may have been compromised, were distributed.
Product Quantity17 components
Recall NumberB-0415-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW067311002604; W067311002662; W067310026142A; W067310026142B; W067311002329; W067311002722; W067311002338
ClassificationClass II
Reason for RecallBlood products, for which the sterility may have been compromised, were distributed.
Product Quantity7 components
Recall NumberB-0416-13

Class II Devices Event

Event ID60906
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Vascular
CityTemecula
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
 

Associated Products

Product DescriptionBrand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
Code InfoLot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
ClassificationClass II
Reason for RecallThe recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
Product Quantity1253 units (962 units in the US & Puerto Rico)
Recall NumberZ-0757-2013

Class II Devices Event

Event ID61611
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.
 

Associated Products

Product DescriptionAdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Code InfoMfg Lot or Serial # 00000L022E05AE 00000139595HP3 000000010003GS 000000410012GS 000000210016GS 000000210013GS 00000138998HP0 00000139435HP2 000000410010GS 000000410009GS 000000210005GS 000000210011GS 000000210012GS 000000210015GS 00000138991HP5 000000210014GS 000000310005GS 00000139574HP8 00000139604HP3 00000L026CC222 000000210010GS 000000010004GS 000000410011GS 000000410007GS 000000210023GS 000000210025GS 000000210026GS 000000210022GS 000000210024GS 000000410005GS 000000410006GS 000000310003GS 000000310002GS 000000210006GS 000000210007GS 000000210003GS 000000410004GS 000000310001GS 000000010001GS 000000210030GS 000000210008GS 000000410016GS 000000P8059001 000000210027GS 000000410008GS 000000410001GS 000000210017GS 000000210019GS 000000210021GS 000000210020GS 000000310008GS 000000210018GS 000000410014GS 000000210029GS 000000210004GS 000000210001GS 000000210009GS 000000410003GS 000000410013GS 000000210028GS 000000410017GS 000000410015GS 000000310007GS 000000310006GS 000000010005GS
ClassificationClass II
Reason for RecallIt was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient.
Product Quantity65
Recall NumberZ-0754-2013

Class II Devices Event

Event ID61870
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMotorola Inc
CityHoltsville
StateNY
CountryUS
Distribution PatternNationwide distribution
 

Associated Products

Product DescriptionMotorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
Code InfoMotorola Solutions PCS3000/CS3070 Laser
ClassificationClass II
Reason for RecallIt was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
Product Quantity16,961 units domestically
Recall NumberZ-0516-2013

Class II Devices Event

Event ID61879
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc.
CityCharlottesville
StateVA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionRectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code InfoAll lots
ClassificationClass II
Reason for RecallA medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Product Quantity344 pieces
Recall NumberZ-0759-2013
Product DescriptionRectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code InfoAll lots
ClassificationClass II
Reason for RecallA medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Product Quantity152 units
Recall NumberZ-0760-2013

Class II Devices Event

Event ID63485
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMOOG Medical Devices Group
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
 

Associated Products

Product DescriptionInfinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Code Info003, 509350004, 509350005, 509350006, 509350007, 509350008, 509350009, 509350010, 509350011, 509350012, 509350013, 509350014, 509350015, 509350016, 509350017, 509350018, 509350019, 509350020, 509350021, 509350022, 509350023, 509350024, 509350025, 509350026, 509350027, 509350028, 509350029, 509350030, 509350031, 509350032, 509350033, 509350034, 509350035, 509350036, 509350037, 509350038, 509350039, 509350040, 509350041, 509350042, 509350043, 509350044, 509350045, 509350046, 509350047, 509350048, 509350049, 509350050, 509350051, 509350052, 509350053, 509350054, 509350055, 509350056, 509350057, 509350058, 509350059, 509350060, 509350061, 509350062, 509350063, 509350064, 509350065, 509350066, 509350067, 509350068, 509350069, 509350070, 509350071, 509350072, 509350073, 509350074, 509350075, 509350076, 509350077, 509350078, 509350079, 509350080, 509350081, 509350082, 509350083, 509350084, 509350085, 509350086, 509350087, 509350088, 509350089, 509350090, 509350091, 509350092, 509350093, 509350094, 509350095, 509350096, 509350097, 509350098, 509350099, 509350100, 509350101, 509350102, 509350103, 509350104, 509350105, 509345014, 509345015, 509345016, 509345017, 509345018, 509345019, 509345020, 509345021, 509345005, 509345006, 509345007, 509345008, 509345009, 509351011, 509351012, 509351013, 509351014, 509351015, 509351016, 509351017, 509351018, 509351019, 509351020, 509351021, 509351022, 509351023, 509351024, 509351025, 509351026, 509351027, 509351028, 509351029, 509351030, 509351031, 509351032, 509351033, 509351034, 509351035, 509351038, 509351037, 509351003, 509351004, 509351005, 509351006, 509351007, 509351008, 509351009, 509351010, 509351036, 509351039, 509351040, 509351041, 509351042, 509351043, 509351049, 509351050, 509351051, 509351052, 509351053, 509351054, 509351055, 509351056, 509351057, 509351058, 509351059, 509351060, 509351061, 509351062, 509351063, 509351064, 509351065, 509351066, 509351067, 509351068, 509351069, 509351070, 509351071, 509351072, 509351073, 509351048, 509351047, 509351046, 509351045, 509351044, 509351103, 509351102, 509351101, 509351100, 509351099, 509351098, 509351097, 509351096, 509351095, 509351094, 509351093, 509351092, 509351091, 509351090, 509351089, 509351088, 509351087, 509351086, 509351085, 509351084, 509351083, 509351082, 509351081, 509351080, 509351079, 509351078, 509351077, 509351076, 509351075, 509351074, 509351112, 509351127, 509351128, 509351129, 509351130, 509351131, 509351132, 509351113, 509351114, 509351115, 509351116, 509351117, 509351118, 509351119, 509351120, 509351121, 509351122, 509351123, 509351124, 509351125, 509351126, 509351133, 509351134, 509351135, 509351136, 509351137, 509351138, 509351106, 509351105, 509351107, 509351108, 509351109, 509351111, 509351110, 509351104, 509357071, 509357070, 509357069, 509357068, 509357067, 509357077, 509357076, 509357075, 509357074, 509357073, 509357072, 509357066, 509357065, 509357064, 509357063, 509357062, 509351154, 509357030, 509351156, 509351157, 509357031, 509351158, 509357055, 509351159, 509351160, 509351153, 509357034, 509357033, 509351152, 509351151, 509357056, 509351150, 509351149, 509351161, 509357035, 509357036, 509351148, 509357032, 509351146, 509351145, 509351144, 509351143, 509357037, 509357038, 509357039, 509351162, 509351163, 509351164, 509357040, 509351142, 509351141, 509351140, 509351139, 509351165, 509357041, 509351166, 509351167, 509357042, 509357043, 509357044, 509357045, 509357046, 509357047, 509351168, 509351155, 509357049, 509351170, 509357050, 509357051, 509357052, 509357053, 509351171, 509351172, 509357001, 509357002, 509357003, 509357004, 509357005, 509357006, 509357007, 509357008, 509357009, 509357010, 509357057, 509357011, 509357012, 509357013, 509357054, 509357014, 509357061, 509357015, 509357016, 509357017, 509357018, 509357019, 509357020, 509357021, 509357022, 509357058, 509357023, 509357024, 509357025, 509357026, 509357027, 509357028, 509357029, 509357059, 509357060, 509351169, 509357048, 509351147, 509357078, 50
ClassificationClass II
Reason for RecallThe firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Product Quantity92,488 units
Recall NumberZ-0764-2013

Class II Biologics Event

Event ID63593
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036812426425;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0413-13

Class II Biologics Event

Event ID63595
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141610155472;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0427-13
Product DescriptionFresh Frozen Plasma
Code InfoW141610154831;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0428-13
Product DescriptionRed Blood Cells
Code InfoW141610157832; W141610157430;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0429-13

Class II Biologics Event

Event ID63625
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW038112114651A; W038112114651B;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2
Recall NumberB-0414-13

Class II Biologics Event

Event ID63627
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternCalifornia; Washington
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141610018913; W141610048862;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0420-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141611017625;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0421-13

Class II Biologics Event

Event ID63636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW044112124744;
ClassificationClass II
Reason for RecallBlood product, which tested negative for viral markers, but was collected from a donor that subsequently reported a previous history of positive test hepatitis, was distributed.
Product Quantity1
Recall NumberB-0422-13

Class II Biologics Event

Event ID63637
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036812538893;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-0423-13

Class II Biologics Event

Event ID63638
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternColorado
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036212518486;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-0424-13

Class II Biologics Event

Event ID63639
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionPlatelets
Code InfoW333612094877;
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0425-13

Class II Devices Event

Event ID63800
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
CityMahwah
StateNJ
CountryUS
Distribution PatternUS Nationwide Distribution including the states of: VA, TN, FL, & TX
 

Associated Products

Product DescriptionMindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Code Infop/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 0C000569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
ClassificationClass II
Reason for RecallMindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Product Quantity13 units
Recall NumberZ-0742-2013

Class II Devices Event

Event ID63805
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmExtremity Medical LLC
CityParsippany
StateNJ
CountryUS
Distribution PatternWorldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.
 

Associated Products

Product DescriptionExtremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant.
Code InfoCatalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08.
ClassificationClass II
Reason for RecallLag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Product Quantity93 units
Recall NumberZ-0752-2013

Class II Devices Event

Event ID63827
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCordis Corporation
CityMiami Lakes
StateFL
CountryUS
Distribution PatternUS (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
 

Associated Products

Product DescriptionCordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device REF cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Code InfoModel EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768. Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623, 15426890, 15430798, 15433095, 15433098, 15441594, 15443327, 15446063, 15448005, 15451542, 15452987, 15455770, 15455771, 15459366, 15459367, 15461179, 15461781, 15463296, 15463297, 15464298, 15464299, 15466362, 15472044, 15475128, 15475795, 15479644, 15484135, 15487458, 15491737, 15496311, 15497038, 15500078, 15500709, 15503015, 15504223, 15504224, 15504748, 15506926, 15508012, 15508353, 15508856, 15510541, 15512713, 15518232, 15540529, 15545067, 15548555, 15549324, 15550196, 15550197, 15557284, 15561545, 15561546, 15566744, 15572185, 15573480, 15579468, 15585121, 15587184, 15596793, 15601234, 15601753, 15604477, 15605089, 15609335, 15613282, 15617549, 15625033, 15627316, 15635233, 15637262, 15643624, 15644116, 15644789, 15644790, 15649759, 15663330. Model EX700 Lot #'s: 15466361, 15471271, 15471272, 15476317, 15476743, 15482155, 15483371, 15486224, 15490397, 15535011, 15540530.
ClassificationClass II
Reason for RecallOn 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.
Product Quantity98,675 units distributed in US.
Recall NumberZ-0740-2013

Class II Food Event

Event ID63865
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGeneral Mills, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternAZ, CA, HI, ID, MT, OR, UT, WA GUAM, AMERICAN SAMOA, MEXICO, SINGAPORE, PAPUA NW GUINEA.
 

Associated Products

Product DescriptionBetty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000
Code InfoConsumer package code: Better Used By 14SEP2013 Case code: 14SEP3LD
ClassificationClass II
Reason for RecallGeneral Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake because of a labeling issue. Some product was packaged incorrectly, and contains undeclared FDandC color ingredient not listed on the box's ingredient label. The undeclared colors are: Yellow 5, Yellow 6, Red 40 and Blue 1.
Product Quantity6223 cases (12 consumer packages / case)
Recall NumberF-0936-2013

Class II Devices Event

Event ID63866
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlfa Wassermann, Inc.
CityW Caldwell
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
 

Associated Products

Product DescriptionAlfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Code InfoLot Number 155599
ClassificationClass II
Reason for RecallInorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Product Quantity4,104 kits
Recall NumberZ-0743-2013

Class II Devices Event

Event ID63868
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternUS Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
 

Associated Products

Product DescriptionJuno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Code InfoSerial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
ClassificationClass II
Reason for RecallValues of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21
Product Quantity16 units
Recall NumberZ-0702-2013

Class II Devices Event

Event ID63875
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEnvoy Medical Corporation
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.
 

Associated Products

Product DescriptionEsteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
Code InfoLot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053 Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510 Lot# EMC0004304 EMC0004797 Lot# EMC0003827 EMC0004233
ClassificationClass II
Reason for RecallEnvoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
Product Quantity44
Recall NumberZ-0750-2013

Class II Drugs Event

Event ID63879
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSchering-Plough Products, LLC
CityLas Piedras
StatePR
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionTemodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Code InfoLot: 0NCW005, Exp 02/2013
ClassificationClass II
Reason for RecallFailed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Product Quantity17,169 Packages
Recall NumberD-139-2013

Class II Devices Event

Event ID63934
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrtho-Clinical Diagnostics
CityRochester
StateNY
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.
 

Associated Products

Product DescriptionOrtho Clinical Diagnostics VITROS® Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS® Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS® 3600, VITROS® 5600, and VITROS® ECi/ECiQ Systems.
Code InfoCAT No. 680 0100; the cartridges do not have lot numbers.
ClassificationClass II
Reason for RecallSome VITROS® Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS® System instead of the intended VITROS® Vapor Adsorption Cartridge which may bias results.
Product QuantityDomestic: 15,891; Foreign: 5237
Recall NumberZ-0755-2013

Class II Food Event

Event ID63982
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmChocolate Decadence
CityEugene
StateOR
CountryUS
Distribution PatternProduct was distributed in Arkansas California, Florida, Georgia, Indiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Virginia, Washington, West Virginia, Wisconsin,
 

Associated Products

Product DescriptionChocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package) or in 0.5 lb and 1 lb. boxes. The 2-ounce package has a UPC 19815 90007 8. There is no UPC for 0.5 lb. and 1 lb. packages. The product is labeled in parts: "***Chocolate Covered Coconut Balls***CHOCOLATE DECADENCE***Net Wt. 2oz (56.7g)***INGREDIENTS: Semi-sweet chocolate (sugar,
Code InfoNone
ClassificationClass II
Reason for RecallThere is a potential of cross contamination with peanuts. The Chocolate Covered Coconut Balls were dipped in the same pot of melting chocolate that was used to make product containing peanut butter.
Product Quantity46/2 oz. packages; 5/1 lb. boxes; and 2/0.5 lbs boxes
Recall NumberF-0940-2013

Class II Devices Event

Event ID63997
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmRoche Molecular Systems, Inc.
CityBranchburg
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
 

Associated Products

Product DescriptionCOBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Code InfoMaterial Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
ClassificationClass II
Reason for RecallThe COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
Product Quantity335 CE-IVD TDFs; 48 JPN-IVD TDFs
Recall NumberZ-0762-2013

Class II Devices Event

Event ID64004
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
 

Associated Products

Product DescriptionTUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Code InfoCatalog Number: 909668 Lot Number Identification: 716710
ClassificationClass II
Reason for RecallThru hole at the tip of the screw is undersized.
Product Quantity44 units distributed
Recall NumberZ-0753-2013

Class II Devices Event

Event ID64008
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.
 

Associated Products

Product DescriptionBBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.
Code InfoLot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013
ClassificationClass II
Reason for RecallEnrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Product Quantity11,710 tubes
Recall NumberZ-0739-2013

Class II Devices Event

Event ID64010
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Company
CityFranklin Lakes
StateNJ
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
 

Associated Products

Product DescriptionBD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Code InfoLot No. 2180434; Expiration Date: April 2013
ClassificationClass II
Reason for RecallBD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
Product Quantity2,944,700 units
Recall NumberZ-0756-2013

Class II Food Event

Event ID64011
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 FirmEonNutra, LLC
CityColorado Springs
StateCO
CountryUS
Distribution PatternNationwide, AR, CA, CO, FL, GA, IO, MI, MO, NC, ND, NE, NJ, SC, TN, TX, UT, WI
 

Associated Products

Product DescriptionGrowth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow. Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers, pharmaceutical laboratories and governmental research facilities.
Code InfoSRK91512; SRK92112; SRK92512; SRK102312; SRK11412; SRK111912.
ClassificationClass II
Reason for RecallEon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria.
Product Quantity199 x 2 oz bottles
Recall NumberF-0937-2013

Class II Drugs Event

Event ID64020
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHillyard GMP
CitySaint Joseph
StateMO
CountryUS
Distribution PatternDistribution nationwide
 

Associated Products

Product DescriptionHILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Code InfoLot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Product Quantity2,139 bottles
Recall NumberD-140-2013

Class II Food Event

Event ID64021
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmC H S Inc
CityHutchinson
StateKS
CountryUS
Distribution PatternDistribution was made to MI, KY, WI, OH,
 

Associated Products

Product DescriptionKitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628
Code InfoLot 12257 and Lot 12258
ClassificationClass II
Reason for RecallThe product contains Soy and Wheat and is packaged in cartons in which the ingredient statement is missing.
Product Quantity2,474 containers
Recall NumberF-0962-2013

Class II Devices Event

Event ID64054
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmbioMerieux, Inc.
CityDurham
StateNC
CountryUS
Distribution PatternWorldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
 

Associated Products

Product DescriptionBacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Code InfoCatalog Number: 259789, Lots/Batch: 1031866
ClassificationClass II
Reason for RecallBacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Product Quantity1690 cases
Recall NumberZ-0738-2013

Class II Devices Event

Event ID64055
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon Endo-Surgery Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.
 

Associated Products

Product DescriptionEthicon Endo-Surgery Inc. The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
Code InfoProduct Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017. Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017. Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017, Lot # J4AX37, Exp. Date 5-2017, Lot # J4AX5Z, Exp. Date 5-2017, Lot # J4AX6E, Exp. Date 5-2017, Lot # J4AX8T, Exp. Date 5-2017, Lot # J4AX8U, Exp. Date 5-2017, Lot # J4AZ3P, Exp. Date 6-2017, Lot # J4AZ3V, Exp. Date 6-2017, Lot # J4AZ4W, Exp. Date 6-2017, Lot # J4AZ51, Exp. Date 6-2017, Lot # J4C11M, Exp. Date 6-2017, Lot # J4C11H, Exp. Date 6-2017, Lot # J4C15E, Exp. Date 6-2017, Lot # J4C17G, Exp. Date 6-2017, Lot # J4C174, Exp. Date 6-2017, Lot #, J4C187, Exp. Date 6-2017, Lot # J4C197, Exp. Date 6-2017, Lot # J4C17Y, Exp. Date 6-2017, Lot # J4C19M, Exp. Date 6-2017, Lot #, J4C225, Exp. Date 6-2017, Lot # J4C22H, Exp. Date 6-2017, Lot # J4C358, Exp. Date 6-2017, Lot # J4C35C, Exp. Date 6-2017, Lot # J4C36T, Exp. Date 6-2017, Lot # J4C427, Exp. Date 7-2017, Lot # J4C42D, Exp. Date 7-2017, Lot # J4C44P, Exp. Date 7-2017, Lot # J4C51U, Exp. Date 7-2017, Lot # J4C51W, Exp. Date 7-2017, Lot # J4C56E, Exp. Date 7-2017, Lot # J4C56A, Exp. Date 7-2017, Lot # J4C56Z, Exp. Date 7-2017, Lot # J4C56P, Exp. Date 7-2017, Lot # J4C58J, Exp. Date 7-2017, Lot # J4C58V, Exp. Date 7-2017, Lot # J4C65M, Exp. Date 7-2017, Lot # J4C66A, Exp. Date 7-2017, Lot # J4C66L, Exp. Date 7-2017, Lot # J4C758, Exp. Date 7-2017, Lot # J4C768, Exp. Date 7-2017, Lot # J4C85H, Exp. Date 7-2017, Lot # J4C85W, Exp. Date 7-2017, Lot # J4C906, Exp. Date 7-2017, Lot # J4C96P, Exp. Date 8-2017, Lot # J4C96Z, Exp. Date 8-2017, Lot # J4C879, Exp. Date 7-2017, Lot # J4CA4X, Exp. Date 8-2017, Lot # J4CA4Y, Exp. Date 8-2017, Lot # J4CC01, Exp. Date 8-2017, Lot # J4CC2G, Exp. Date 8-2017, Lot # J4CC4J, Exp. Date 8-2017, Lot # J4CD0C, Exp. Date 8-2017, Lot # J4CE10, Exp. Date 8-2017, Lot # J4CE16, Exp. Date 8-2017, Lot # J4CF0J, Exp. Date 8-2017, Lot # J4CF66, Exp. Date 9-2017, Lot # J4CJ0L, Exp. Date 9-2017, Lot # J4CJ5Z, Exp. Date 9-2017, Lot # J4CJ6J, Exp. Date 9-2017 and Lot # J4CK1K, Exp. Date 9-2017. Product Code NSLG2C45, Lot # H44W26, Exp. Date 10-2013, Lot # H44W25, Exp. Date 10-2013, Lot # H44W27, Exp. Date 10-2013, Lot # J4A19D, Exp. Date 12-2013, Lot # J4AR6G, Exp. Date 4-2017, Lot # J4AU2R, Exp. Date 5-2017, Lot # J4AV5U, Exp. Date 5-2017, Lot # J4AZ53, Exp. Date 6-2017, Lot # J4C042, Exp. Date 6-2017, Lot # J4C122, Exp. Date 6-2017, Lot # J4C18F, Exp. Date 6-2017, Lot # J4C23J, Exp. Date 6-2017, Lot # J4C270, Exp. Date 6-2017, Lot # J4C32F, Exp. Date 6-2017, Lot # J4C62J, Exp. Date 7-2017, Lot # J4C62P, Exp. Date 7-2017, Lot # J4C816, Exp. Date 7-2017, Lot # J4C90E, Exp. Date 7-2017, Lot # J4C90F, Exp. Date 7-2017, Lot # J4C99K, Exp. Date 8-2017, Lot # J4CA8M, Exp. Date 8-2017, Lot # J4CD6Z, Exp. Date 8-2017, Lot # J4CJ73, Exp. Date 9-2017 and Lot # J4CK5E, Exp. Date 9-2017. Product Code NSLG2S14, Lot # H44Z5R, Exp. Date 11-2013, Lot # J4C312, Exp. Date 6-2017, Lot # J4C639, Exp. Date 7-2017 and Lot # J4CG7Z, Exp. Date 9-2017. Product Code NSLG2S25, Lot # H44Z57, Exp. Date 11-2013, Lot # J4AU2W, Exp. Date 5-2017, Lot # J4AW4P, Exp. Date 5-2017, Lot # J4AW4N, Exp. Date 5-2017, Lot # J4AX4W, Exp. Date 5-2017, Lot # J4AZ5M, Exp. Date 6-2017, Lot # J4C09V, Exp. Date 6-2017, Lot # J4C18R, Exp. Date 6-2017, Lot # J4C22J, Exp. Date 6-2017, Lot # J4C27C, Exp. Date 6-2017, Lot # J4C34E, Exp. Date 6-2017, Lot # J4C34F, Exp. Date 6-2017, Lot # J4C34K, Exp. Date 6-2017, Lot # J4C37R, Exp. Date 6-2017, Lot # J4C49E, Exp. Date 7-2017, Lot # J4C49G, Exp. Date 7-2017, Lot # J4C576, Exp. Date 7-2017, Lot # J4C577, Exp. Date 7-2017, Lot # J4C63W, Exp. Date 7-2017, Lot # J4C67U, Exp. Date 7-2017, Lot # J4C75N, Exp. Date 7-2017, Lot # J4C75X, Exp. Date 7-2017 and Lot # J4C92G, Exp. Date 7-2017. Product Code NSLG2S35, Lot # H44Y6N, Exp. Date 11-2013, Lot # H44Y8A, Exp. Date 11-2013, Lot # H44Y8K, Exp. Date 11-2013, Lot # H44Z65, Exp. Date 11-2013, Lot # H44Z6J, Exp. Date 11-2013, Lot # J4A164, Exp. Date 12-2013, Lot # J4AR9C, Exp. Date 4-2017, Lot # J4AT1U, Exp. Date 4-2017, Lot # J4AT22, Exp. Date 4-2017, Lot # J4AT4H, Exp. Date 4-2017, Lot # J4AU2X, Exp. Date 5-2017, Lot # J4AW31, Exp. Date 5-2017, Lot # J4AW36, Exp. Date 5-2017, Lot # J4AW9D, Exp. Date, 5-2017, Lot # J4AW9H, Exp. Date, 5-2017, Lot # J4AX62, Exp. Date, 5-2017, Lot # J4AX8Y, Exp. Date, 5-2017, Lot # J4AX9F, Exp. Date, 5-2017, Lot # J4C100, Exp. Date, 6-2017, Lot # J4C109, Exp. Date, 6-2017, Lot # J4C15H, Exp. Date, 6-2017, Lot # J4C18W, Exp. Date, 6-2017, Lot # J4C209, Exp. Date, 6-2017, Lot # J4C20A, Exp. Date, 6-2017, Lot # J4C23K, Exp. Date, 6-2017, Lot # J4C27E, Exp. Date, 6-2017, Lot # J4C27H, Exp. Date, 6-2017, Lot # J4C32G, Exp. Date, 6-2017, Lot # J4C34M, Exp. Date, 6-2017, Lot # J4C435, Exp. Date, 7-2017, Lot # J4C43J, Exp. Date, 7-2017, Lot # J4C537, Exp. Date, 7-2017, Lot # J4C53G Exp. Date, 7-2017, Lot # J4C53T, Exp. Date, 7-2017, Lot # J4C57N, Exp. Date, 7-2017, Lot # J4C57P, Exp. Date, 7-2017, Lot # J4C64N, Exp. Date, 7-2017, Lot # J4C64U, Exp. Date, 7-2017, Lot # J4C73T, Exp. Date, 7-2017, Lot # J4C73X, Exp. Date, 7-2017, Lot # J4C914, Exp. Date, 7-2017, Lot # J4C90W, Exp. Date, 7-2017, Lot # J4C92Z, Exp. Date, 7-2017, Lot # J4CE93, Exp. Date, 8-2017 and Lot # J4CC02, Exp. Date, 8-2017. Product Code NSLG2S45, Lot # J4A12R, Exp. Date 12-2013, Lot # J4AV6G, Exp. Date 5-2017, Lot # J4AV6T, Exp. Date 5-2017, Lot # J4AX9V, Exp. Date 5-2017, Lot # J4C15V, Exp. Date 6-2017, Lot # J4C30V, Exp. Date 6-2017, Lot # J4C37T, Exp. Date 6-2017, Lot # J4C67E, Exp. Date 7-2017, Lot # J4C67J, Exp. Date 7-2017, Lot # J4C67M, Exp. Date 7-2017, Lot # J4C74T, Exp. Date 7-2017 and Lot # J4CC9G, Exp. Date 8-2017.
ClassificationClass II
Reason for RecallEthicon Endo-Surgery initiated a voluntary global recall for all production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to a potential for self activation while the device is in use, which may result in unintended thermal damage.
Product Quantity58,338 Instruments
Recall NumberZ-0758-2013

Class II Food Event

Event ID64082
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGordon Food Service, Inc.
CityPlant City
StateFL
CountryUS
Distribution PatternFlorida only
 

Associated Products

Product Description***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***.
Code InfoProduct ID# 536030, best by Feb 12 2013
ClassificationClass II
Reason for RecallConcern with Time/Temperature abused during transit.
Product Quantity10 cases
Recall NumberF-0952-2013

Class II Food Event

Event ID64101
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDawn's Foods, Inc.
CityPortage
StateWI
CountryUS
Distribution PatternIL, IA, WI
 

Associated Products

Product DescriptionOcean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc.
Code Info1/9/13 -3/05/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity6,940 lbs
Recall NumberF-0953-2013
Product DescriptionOcean Harbor Cajun Krab Spread Net Wt 5 lb (2.27 kg) UPC: 0 32345-77711 8 Dist by Roundy's Inc.
Code Info1/9/13 -3/05/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity3,130 lbs
Recall NumberF-0954-2013
Product DescriptionOcean Harbor Jalapeno Krab Spread Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6 Dist by Roundy's Inc.
Code Info1/9/13 -3/05/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity1,250 lbs
Recall NumberF-0955-2013
Product DescriptionFive Star Dip Smoked Salmon Dip Net WT 10 oz (284g). UPC: 0 32345 61463 5 Mfg By Dawn Food, Portage, WI 53901. Dawns Smoked Salmon Dip NET WT 5 LBS (2.27 kg) UPC: 0 32345 61480 2 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901
Code Info1/9/13 -3/05/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity11,841 lbs
Recall NumberF-0956-2013
Product DescriptionFive Star Dip Cajun Krab Dip Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901. 84080 Dawns Cajun Krab Dip NET WT 5 LBS (2.27 kg), UPC: 0 32345 88888 3 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901
Code Info1/9/13 -3/05/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity4,176 lbs
Recall NumberF-0957-2013
Product DescriptionDawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 70103 8 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 Ocean Harbor Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77701 9 Dist by Roundy's Inc.
Code Info1/9/13 -2/19/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity7,470 lbs
Recall NumberF-0958-2013
Product DescriptionDawns Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 85072 9 , MFG BY DAWN'S FOODS, IN., PORTAGE, WI 53901 Ocean Harbor Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77705 7, Dist by Roundy's Inc.
Code Info1/9/13 -2/19/13
ClassificationClass II
Reason for RecallDawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity10,635 lbs
Recall NumberF-0959-2013

Class II Devices Event

Event ID64129
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreatbatch Medical
CityMinneapolis
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.
 

Associated Products

Product Description45° Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
Code InfoAll lots
ClassificationClass II
Reason for RecallGreatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45° product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
Product Quantity913
Recall NumberZ-0751-2013

Class II Drugs Event

Event ID64154
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Pharmaceuticals Inc.
CityMorgantown
StateWV
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionCarvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Code InfoLot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
ClassificationClass II
Reason for RecallFailed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Product Quantity11,580 bottles
Recall NumberD-137-2013

Class III Biologics Event

Event ID40843
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoC72367
ClassificationClass III
Reason for RecallBlood product, which did not have the correct amount red cell preservative solution added, was distributed.
Product Quantity1 Unit
Recall NumberB-0494-13

Class III Biologics Event

Event ID41266
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-05
Initial Firm Notification of Consignee or Public Other
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoGH01615; GH00089
ClassificationClass III
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 Units
Recall NumberB-0471-13

Class III Biologics Event

Event ID44158
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityDenton
StateTX
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info06DTXC0279
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0330-13

Class III Biologics Event

Event ID48264
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityEl Paso
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info115998840
ClassificationClass III
Reason for RecallBlood products, which were possibly contaminated, were distributed.
Product Quantity1 unit
Recall NumberB-0260-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info115998840
ClassificationClass III
Reason for RecallBlood products, which were possibly contaminated, were distributed.
Product Quantity1 unit
Recall NumberB-0261-13

Class III Biologics Event

Event ID49814
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternAustria.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW141608007333
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
Product Quantity1 component
Recall NumberB-0491-13

Class III Biologics Event

Event ID51265
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityDedham
StateMA
CountryUS
Distribution PatternMA, ME, NH, NY, PA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info004E25878, 004E25879, 004F77446, 004FJ44307, 004FJ44310, 004J10528, 004J10531, 004N71839, 004N71842, 004N71862, 004N71866, 004N71867, 004N71875
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity13 units
Recall NumberB-0334-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info004E25855, 004E25857, 004E25868, 004F77410, 004F77419, 004F77468, 004FJ44301, 004FJ44308, 004J10538, 004J10546, 004M56906
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity11 units
Recall NumberB-0335-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info004FG06539 (Parts 1 & 2), 004FH06057 (Parts 1 & 2), 004FP94622 (Parts 1 & 2), 004FP94628, 004FP94631
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity8 units
Recall NumberB-0336-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2)
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity24 units
Recall NumberB-0337-13

Class III Biologics Event

Event ID63594
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW141610132562;
ClassificationClass III
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0426-13

Class III Devices Event

Event ID63918
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
 

Associated Products

Product DescriptionAlere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
Code InfoLot#C2510 and C2510A
ClassificationClass III
Reason for RecallAlere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.
Product Quantity2,471 kits
Recall NumberZ-0746-2013
Product DescriptionAlere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Code InfoLot#271097
ClassificationClass III
Reason for RecallAlere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.
Product Quantity320 kits
Recall NumberZ-0747-2013

Class III Food Event

Event ID63977
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe Father's Table, LLC
CitySanford
StateFL
CountryUS
Distribution PatternDOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin INTERNATIONAL: Trinidad and Tobago
 

Associated Products

Product DescriptionIndividual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: "The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.***
Code InfoUPC' #s = L72483N, L49983N, and L49983N SKU # 49983, 72483, and 63583
ClassificationClass III
Reason for RecallIncorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).
Product Quantity3,733 cartons / 12 rolls / 8 oz ea
Recall NumberF-0938-2013
Product DescriptionIndividual packages labeled in part: ***The Bakery baked with pride***Vanilla Mini Cake Roll***8oz**** with strawberry filling*** NETWT 8oz (226g)
Code InfoUPC' #s = L02367N SKU # 02367
ClassificationClass III
Reason for RecallIncorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).
Product Quantity5,535 cases / 12 rolls / 8oz ea
Recall NumberF-0939-2013

Class III Food Event

Event ID63978
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmJ F C International Inc
CityLos Angeles
StateCA
CountryUS
Distribution Patternnationwide in the US
 

Associated Products

Product DescriptionWP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz.
Code InfoJFC# Lot# 15603 Q066A & Q109A; 06315 Q065A & Q108A; 07266 Q067A & Q110A; 06375 Q066A & Q109A.
ClassificationClass III
Reason for RecallJFC International is recalling WelPac Saki Ika Cuttlefish because of mold.
Product Quantity500 cartons
Recall NumberF-0950-2013
Product DescriptionWP Saki Ika Cuttlefish Hot JFC# 15606, 4/24/0.75 oz; JFC# 06318, 8/12/2 oz; JFC# 07269, 5/12/4 oz; JFC# 06360, 3/12/8 oz.
Code InfoJFC# Lot# 15606 Q069A & Q110A; 06318 Q068A & Q111A; 07269 Q070A & Q112A; 06360 Q069A & Q112A.
ClassificationClass III
Reason for RecallJFC International is recalling WelPac Saki Ika Cuttlefish because of mold.
Product Quantity500 cartons
Recall NumberF-0951-2013

Class III Drugs Event

Event ID64014
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWarner Chilcott Company LLC
CityFajardo
StatePR
CountryUS
Distribution PatternUS Nationwide
 

Associated Products

Product DescriptionFemtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Code Info0.9 mg: 512348A
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Product Quantity5439 bottles
Recall NumberD-141-12013
Product DescriptionFemtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Code Info0.45 mg: 505969A
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Product Quantity3155 bottles
Recall NumberD-142-2013

Class III Devices Event

Event ID64081
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionDimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
Code InfoSiemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01.
ClassificationClass III
Reason for RecallSiemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
Product Quantity5999
Recall NumberZ-0745-2013

Mixed Classification Biologics Event

Event ID43710
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS and CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02GG13901
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0435-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info02GG13901
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0436-13

Mixed Classification Biologics Event

Event ID44463
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS and CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LC78216
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0438-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info02LC78216
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0439-13

Mixed Classification Biologics Event

Event ID63626
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCarter BloodCare
CityBedford
StateTX
CountryUS
Distribution PatternNew Jersey; Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0352120385900;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0417-13
Product DescriptionPlatelets
Code InfoW0352120385900; W035212226967D;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0418-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW0352120385900;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0419-13

Mixed Classification Devices Event

Event ID64135
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarestream Health, Inc.
CityRochester
StateNY
CountryUS
Distribution PatternUS Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
 

Associated Products

Product DescriptionKODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
Code InfoLot 2114596 (Exp. September 2014)
ClassificationClass II
Reason for RecallThe company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label.
Product Quantity101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Recall NumberZ-0744-2013
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