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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Class I Devices Event

Event ID64736
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCardinal Health, Medical Products & Services
CityPark City
StateIL
CountryUS
Distribution PatternDistributed in the states of AR, MS, SC, and TN.
 

Associated Products

Product DescriptionPresource PBDS, Gyn Laparoscopy Kit, Circulator
Code InfoCatalog Number: PB24LSNPC01; Lots: 152737, 159630, 168459, 176674, 187217, 197319, 840618
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1193-2013
Product DescriptionA) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Code InfoA) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482, , 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1194-2013
Product DescriptionPresource PBDS, General Laparoscopy, Kit, Circulator
Code InfoCatalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1195-2013
Product DescriptionPresource PBDS, Major Abdominal, Kit, Circulator
Code InfoCatalog Number: PG24MANPC01; Lots: 840143, 857320, 871000, 882315, 900599, 928133, 942238, 952387, 964048
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1196-2013
Product DescriptionPresource PBDS, Knee Arthroscopy, Kit, Circulator
Code InfoCatalog Number: PO24AKNPC01; Lots: 851288, 877594, 901672, 917786, 948443, 972424
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1197-2013
Product DescriptionPresource PBDS, Extremity, Kit, Circulator
Code InfoCatalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1198-2013
Product DescriptionPresource PBDS, Hand, Kit, Circulator
Code InfoCatalog Number: PO24HKGWG01; Lots: 856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1199-2013
Product DescriptionPresource PBDS, Shoulder Arthroscopy, Kit, Circulator
Code InfoCatalog Number: PO24SAGWF01; Lots: 847129, 877843, 905183, 931801, 935180, 946651, 957422, 969585
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1200-2013
Product DescriptionPresource PBDS, Shoulder Procedure, Kit, Circulator
Code InfoCatalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1201-2013
Product DescriptionPresource PBDS, Total Hip, Kit, Circulator
Code InfoCatalog Number: PO24THGWG01; Lots: 966051, 970753
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1202-2013
Product DescriptionPresource PBDS, Total Joint, Kit, Circulator
Code InfoCatalog Number: PO24TJNPC01; Lots: 843134, 851291, 875033, 893475, 911751, 914529, 928726, 948543, 968125,
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1203-2013
Product DescriptionPresource PBDS, Total Knee, Kit, Circulator
Code InfoCatalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1204-2013
Product DescriptionPresource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit
Code InfoCatalog Number:PZ23ANBUG; Lot: 200710
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1205-2013
Product DescriptionPresource PBDS, Knee Arthroscopy, Kit, Circulator
Code InfoCatalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782
ClassificationClass I
Reason for RecallVarious Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Product Quantity4,571 Kits total
Recall NumberZ-1206-2013

Class I Devices Event

Event ID64876
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmAbbott Diabetes Care, Inc.
CityAlameda
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionFreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Code InfoPart Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
ClassificationClass I
Reason for RecallAT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Product Quantity335,273 meters in the US, and 607,137 internationally
Recall NumberZ-1245-2013

Class II Biologics Event

Event ID39504
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-04
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNebraska; Pennsylvania;California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09GV13749; 09GV14552; 09GV15492
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity3 Units
Recall NumberB-1097-13

Class II Biologics Event

Event ID39897
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CityBoise
StateID
CountryUS
Distribution PatternCanada.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20LY55510 , 20LY55518 , 20LS22792 , 20LS22257 , 20LS22898 , 20lC72098 , 20LY56192 , 20LS22666 , 20LS22667 , 20LS22801 , 20LS22923 , 20LS22744 , 20LS22729 , 20LS22746 , 20lS22562, 20LY56070, 20LS22616, 20LS22684 , 20LS22800, 20LS22808 , 20LS22965, 20LS22967, 20LS22997, 20LS23042 , 20LY56948, 20LS22622 , 20LS22757, 20LS22760 , 20LS22865, 20LY56958, 20LS22585, 20LS22594, 20LY56098, 20LY56084, 20LS22354, 20LS22459, 20LY56075, 20LY56090, 20LS22784, 20LS22789, 20LS22794, 20LS22802, 20LS22938, 20LY56087, 20LY56095, 20LS22352, 20LS22487, 20LS22785, 20LS22490, 20LZ27028, 20LS22589, 20LS22726, 20LS22734, 20LS22737, 20LS22721, 20LS22795, 20LS22797, 20LS22804, 20LS22357, 20LY56078.
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 Quantity60 units
Recall NumberB-1134-13
Product DescriptionFresh Frozen Plasma
Code Info20lS22585 , 20LS22487 , 20LS22490 , 20LS22594 , 20LS22622 , 20LS22794 , 20LS22784 , 20LS22789 , 20LS22800 , 20LS22801 , 20LS22808 , 20LS22744 , 20LY56070, 20LS22797, 20LS22792, 20LS22357, 20LY56098, 20LS22352, 20LS22804, 20LS22354, 20LY56084, 20LY56087, 20LC72098, 20LS22785.
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 Quantity24 units
Recall NumberB-1135-13
Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code Info20LS22919.
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-1136-13
Product DescriptionPlasma Frozen
Code Info20LS22612, 20LS22562, 20LY56192.
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 Quantity3 units
Recall NumberB-1137-13

Class II Biologics Event

Event ID40591
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jul-05
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO, IL, AL, SC, MI, PR, France
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11KC13068 11KL07945 11KL08058 11LZ28121 11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 11LE26225 11LC92484 11LC92498 11KL08331 11KL08340 11KL08348 11KL08351 11KL08352 11KL08440 11KL08455 11KL08479 11LQ39167 11LQ39169 11LQ39171 11LQ39175 11LQ39217 11LQ39227 11KE50300 11KE50301 11KE50305 11KE50306 11KE50310 11KE50320 11KE50321 11KE50326 11LE26545 11LE26548 11LE26554 11LE26563 11LE26575 11LE26622 11LE26627 11LE26632 11LE26687 11KY07350 11KY07378 11LE27054 11KV05165 11KV05167 11KV05184 11LE27087 11LE27171 11LE27182 11LE27187 11LE27199 11KV05213 11KV05223 11KV05225 11KV05291 11KY07612 11KY07615 11KY07641 11KY07642 11KY07645 11KY07647 11KY07668 11KY07670 11LC92853 11LC92861 11LE27516 11LE27590 11KY07906 11LE27631 11LE27638 11LE27681 11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84932 11LC93202 11LC93210 11LC93211 11FK12571 11FK12573 11FK12582 11FK12689 11FK12691 11FK12693 11FK12694 11FK12708 11FK12709 11FK12710 11LJ92818 11LJ92822 11LJ92828 11LJ92830 11LJ92837 11KY08219 11KY08225 11KV06093 11KV06098 11KV06115 11KV06117 11KV06120 11KV06122 11KV06126 11KV06140 11KV06203 11KV06217 11KV06226 11KV08262 11KV06095 11KV06102 11KV06145 11LE27829
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity116 units
Recall NumberB-1122-13
Product DescriptionPlasma Frozen. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11LE26225 11LE26231 11LE26234 11LC92535 11KE50301 11KE50310 11KE50315 11KE50320 11KE50321 11KE50326 11KE50329 11LE26545 11LE26563 11LE26687 11LE26697 11LE27044 11KV05167 11LE27080 11LE27087 11LE27154 11LE27175 11KV05273 11KY07615 11KY07633 11KY07639 11KY07645 11LC92861 11LE27502 11KV05636 11KV05639 11LE27581 11LJ92554 11LJ92559 11LJ92562 11LE27587 11LE27589 11LE27590 11LE27631 11LE27638 11LE27681
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity40 units
Recall NumberB-1123-13
Product DescriptionRed Blood Cells. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11LC92381 11LC92384 11LC92388 11LC92390 11LE26231 11LE26234 11LC92535 11LQ39216 11LE26681 11LE26697 11LE26704 11LE26741 11LE27040 11LE27044 11LE27052 11KV05210 11KV05217 11KV05220 11KV05244 11LQ39475 11LQ39479 11LQ39501 11LQ39502 11KV05273 11KV05292 11KY07606 11KY07607 11KY07633 11KY07639 11LC92854 11LC92855 11LC92857 11LC92858 11KV05636 11KV05639 11KV05640 11KV05642 11KV05644 11KV05646 11KV05655 11LE27581 11LE27583 11KV05688 11KV05698 11KV05700 11LJ92554 11LJ92558 11LJ92559 11LJ92562 11LJ92568 11LJ92570 11LE27589 11LE27629 11LE27632 11LE27636 11LE27650 11LE27652 11LE27657 11LE27658 11LE27660 11LQ40040 11LQ40042 11LQ40045 11LQ40060 11LQ40064 11LE27809 11LE27813 11LE27814 11LE27816 11LE27826 11FK12725 11FK12728 11FK12729 11FK12750 11FK12752 11KV06146 11KV06210 11KV06213 11KV06215 11KV06221
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity80 units
Recall NumberB-1124-13
Product DescriptionFresh Frozen Plasma. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity5 units
Recall NumberB-1125-13
Product DescriptionCryoprecipitated AHF. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84930 11GK84932
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity7 units
Recall NumberB-1126-13
Product DescriptionPlatelets. The responsible firm listed on the product label is American Red Cross Blood Services.
Code Info11LE27830
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 unit
Recall NumberB-1127-13

Class II Biologics Event

Event ID44351
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmThe American National Red Cross South Carolina Region
CityColumbia
StateSC
CountryUS
Distribution PatternSouth Carolina, California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info36Q78865
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0965-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info36Q78865
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0966-13

Class II Biologics Event

Event ID45449
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCangene Corporation - Rh Plasma Center
CityWinnipeg
StateMB
CountryCA
Distribution PatternCanada
 

Associated Products

Product DescriptionSource Plasma
Code InfoRH0019179
ClassificationClass II
Reason for RecallBlood product, quality control and distribution/required testing not performed for HIV/HCV Nucleic Acid Test (NAT), was distributed.
Product Quantity1 unit
Recall NumberB-1062-13

Class II Biologics Event

Event ID48527
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3.
Code Info9912770 (Part A); 9912770(Part B); 9912770(Part C)
ClassificationClass II
Reason for RecallBlood products, platelet pheresis leukocytes reduced with an unacceptable pH, were distributed.
Product Quantity3 units
Recall NumberB-1061-13

Class II Biologics Event

Event ID48914
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityCedar Rapids
StateIA
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info08CIAB7249
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was not asked vCJD travel questions, was distributed.
Product Quantity1 Unit
Recall NumberB-1092-13

Class II Biologics Event

Event ID49253
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmFlorida Blood Services, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida, Switzerland.
 

Associated Products

Product DescriptionCryoprecipitate AHF
Code Info4411171
ClassificationClass II
Reason for RecallBlood products, collected from a donor who provided a different last name, were distributed.
Product Quantity1 unit
Recall NumberB-1057-13

Class II Biologics Event

Event ID49633
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternAustria.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing Recovered Plasma Cryoprecipitate Reduced.
Code Info5699436
ClassificationClass II
Reason for RecallBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1056-13

Class II Biologics Event

Event ID50028
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info574252
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1090-13
Product DescriptionRecovered Plasma Frozen within 24 Hour of Phlebotomy (Blood and Blood Products for Reprocessing).
Code Info5575117; 5266741
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-1091-13

Class II Biologics Event

Event ID50638
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info366051639;366053393;366053758;366054269;366055108;366055486;366057062;366058924;366059301;366073292;366073628;366077496
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity12 units
Recall NumberB-1089-13

Class II Devices Event

Event ID60555
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKarl Storz Endoscopy America Inc
CityEl Segundo
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
 

Associated Products

Product DescriptionKARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Code InfoThe device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.
ClassificationClass II
Reason for RecallThe recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.
Product Quantity15 units
Recall NumberZ-1216-2013

Class II Biologics Event

Event ID64051
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross, Penn-Jersey Region
CityPhiladelphia
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info22GM75439;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-1007-13

Class II Biologics Event

Event ID64052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSouth Bend Medical Foundation, Inc.
CitySouth Bend
StateIN
CountryUS
Distribution PatternIndiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045212014473;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1043-13

Class II Biologics Event

Event ID64053
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoM169858;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-1006-13

Class II Biologics Event

Event ID64060
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTalecris Plasma Resources Inc
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info3580167569; 3580167563; 3580167559; 3580167571; 3580167556; 3580167561; 3580167570; 3580168680; 3580168682; 3580168671; 3580168689; 3580168669; 3580168688; 3580168687;
ClassificationClass II
Reason for RecallBlood products, which were not tested for viral markers, were distributed.
Product Quantity14
Recall NumberB-1005-13

Class II Biologics Event

Event ID64087
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Children's Hospital Assoc. Transfusion Medicine Services
CityAurora
StateCO
CountryUS
Distribution PatternColorado
 

Associated Products

Product DescriptionWhole Blood
Code InfoW140512443683;
ClassificationClass II
Reason for RecallBlood product, collected from an autologous donor but incorrectly labeled as a homologous unit, was distributed.
Product Quantity1
Recall NumberB-0408-13

Class II Biologics Event

Event ID64088
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMid-South Regional Blood Center
CityMemphis
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW227712044243; W227712044243;
ClassificationClass II
Reason for RecallBlood products, with pH below the acceptable level, were distributed.
Product Quantity2
Recall NumberB-1008-13

Class II Biologics Event

Event ID64089
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemacare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW313712015322;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1010-13

Class II Biologics Event

Event ID64093
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoP60990;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-1012-13

Class II Biologics Event

Event ID64094
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternOregon
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW137512111712; W137512107157;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Product Quantity2
Recall NumberB-1013-13

Class II Biologics Event

Event ID64095
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW04211091240; W04211091240;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1014-13

Class II Biologics Event

Event ID64096
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info3270201511; 3270200643; 3270200313; 3270198380; 3270198053; 3270197360; 3270196575; 3270196161; 3270193616; 3270192348; 3270191920; 3270191241; 3270190571; 3270190209; 3270189435; 3270189193; 3270188499; 3270188060; 3270187611; 3270186965; 3270186130; 3270185752; 3270185277; 3270184766; 3270184130; 3270183856; 3270179389; 3270178907; 3270177534;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Product Quantity29
Recall NumberB-1015-13

Class II Devices Event

Event ID64444
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternDistributed in the states of CA, FL, GA, NJ, and TX.
 

Associated Products

Product DescriptionBD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Code InfoLot No./Exp. Date: 2237214 / 2013-10-31.
ClassificationClass II
Reason for RecallIncreased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Product Quantity77 kits
Recall NumberZ-1215-2013

Class II Devices Event

Event ID64682
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Endoscopy
CitySan Jose
StateCA
CountryUS
Distribution PatternWorldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
 

Associated Products

Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-403
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1218-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-403
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1219-2013
Product DescriptionStryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-404.
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1220-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number:250-070-407
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1221-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-408.
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1222-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-409
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1223-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-411
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1224-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-437
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1225-2013
Product DescriptionStryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-471
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1226-2013
Product DescriptionStryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-472
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1227-2013
Product DescriptionStryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-473
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1228-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-482
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1229-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-483
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1230-2013
Product DescriptionStryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-484
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1231-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-487
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1232-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-488
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1233-2013
Product DescriptionStryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30° Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-488s2
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1234-2013
Product DescriptionStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-489
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1235-2013
Product DescriptionStryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-490
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1236-2013
Product DescriptionStryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Code InfoManufacturer Part Number: 250-070-491
ClassificationClass II
Reason for RecallThe pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.
Product Quantity147,921 - all sizes
Recall NumberZ-1237-2013

Class II Devices Event

Event ID64696
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityDeerfield
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
 

Associated Products

Product DescriptionA) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.
Code InfoA) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016
ClassificationClass II
Reason for RecallCustomers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Product QuantityA) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
Recall NumberZ-1268-2013
Product DescriptionA) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Code InfoA) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
ClassificationClass II
Reason for RecallCustomers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Product QuantityA) Product Code 2N3371: 228,200 units
Recall NumberZ-1269-2013
Product DescriptionA) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6", Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
Code InfoA) Product Code 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115
ClassificationClass II
Reason for RecallCustomers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Product QuantityA) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) Code 6N8222: 1,200
Recall NumberZ-1270-2013
Product DescriptionA) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
Code InfoA) Product Code 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050
ClassificationClass II
Reason for RecallCustomers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Product QuantityA) Product Code 2N8371: 513,000 units
Recall NumberZ-1271-2013

Class II Devices Event

Event ID64699
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityWest Sacramento
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution including Puerto Rico.
 

Associated Products

Product DescriptionSiemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
Code InfoAll lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13.
ClassificationClass II
Reason for RecallCustomer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Product Quantity21,608 boxes = 432,160 panels
Recall NumberZ-1272-2013

Class II Devices Event

Event ID64705
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSmiths Medical ASD, Inc.
CityKeene
StateNH
CountryUS
Distribution PatternWorldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
 

Associated Products

Product DescriptionWallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code InfoLot Codes: 2000099 2044001 2044005 2117201 2117202 2120953 2138832 2138833 2161554 2304181 2304182 2304199 2305239 2305240 2308138 2313278 2332537 2336956 2336957 2341409 2341410 2344790
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity22380 units
Recall NumberZ-1239-2013
Product DescriptionWallace Sure-Pro Ultra® Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code InfoLot Codes: 2000101 2044006 2044008 2044009 2065654 2117203 2117204 2120950 2138835 2152580 2152582 2156663 2165851 2165852 2170920 2170926 2295309 2304187 2304192 2304193 2304194 2304196 2304197 2304198 2305241 2305243 2313279 2324539 2327973 2327974 2336959 2341411 2341412 2341414 2341415 2341416 2341420
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity59089 units
Recall NumberZ-1240-2013
Product DescriptionWallace Sure-Pro Ultra® Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code Info Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity11550 units
Recall NumberZ-1241-2013
Product DescriptionWallace Sure-Pro® Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code InfoLot codes: 2000100 2025750 2044018 2044019 2065655 2120952 2152589 2152590 2156664 2156665 2170927 2295308 2305235 2305236 2305237 2305238 2308139 2308141 2313280 2313281 2320238 2324603 2336961 2341418 2359095 2363587 2363588 2363589 2363592 2363593 2363594 2363595 2363596 2363597 2363598
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity37620 units
Recall NumberZ-1242-2013
Product DescriptionWallace Sure-Pro® Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code InfoLot Code: 2000103, 2025752, 2161556, 2165854, 2170929, 2304190, 2363603
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity4910 units
Recall NumberZ-1243-2013
Product DescriptionWallace Sure-Pro® Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code InfoLot codes: 2000098 2025748 2041152 2332539 2350024
ClassificationClass II
Reason for RecallUnable to pass catheter through outer sheath during embryo transfer
Product Quantity800 units
Recall NumberZ-1244-2013

Class II Biologics Event

Event ID64767
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNorth Carolina Eye Bank, Inc. (The)
CityWinston Salem
StateNC
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionCornea
Code Info04871302
ClassificationClass II
Reason for RecallHuman corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
Product Quantity1 Cornea
Recall NumberB-1432-13

Class II Devices Event

Event ID64771
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI
 

Associated Products

Product DescriptionSynthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.
Code InfoAll Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.
ClassificationClass II
Reason for RecallThe Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
Product Quantity417
Recall NumberZ-1238-2013

Class II Biologics Event

Event ID64773
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics Inc.
CityBerkeley
StateCA
CountryUS
Distribution PatternUS and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam
 

Associated Products

Product DescriptionMicroCel 500 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710
Code InfoCatalog number 10312319/VG 42115
ClassificationClass II
Reason for RecallMicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
Product Quantity1
Recall NumberB-1448-13
Product DescriptionMicroCel 300 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710
Code InfoCatalog number 10319937/ VG 42044
ClassificationClass II
Reason for RecallMicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
Product Quantity1
Recall NumberB-1449-13

Class II Biologics Event

Event ID64815
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe American National Red Cross - Southern Region
CityDouglasville
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info003LH34364
ClassificationClass II
Reason for RecallBlood product, misbranded as Jkb negative, and subsequently determined to be JKb positive, was distributed.
Product Quantity1 unit
Recall NumberB-1447-13

Class II Devices Event

Event ID64898
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCypress Medical Products LLC
CityMchenry
StateIL
CountryUS
Distribution PatternUS Distribution to the state of VA only.
 

Associated Products

Product DescriptionCypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
Code InfoPart Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.
ClassificationClass II
Reason for RecallCypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.
Product Quantity150 Cases (75,000 Units)
Recall NumberZ-1273-2013

Class II Devices Event

Event ID64913
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.
 

Associated Products

Product DescriptionDePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
Code InfoLot number:13A01
ClassificationClass II
Reason for RecallLabeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Product Quantity27 units
Recall NumberZ-1278-2013

Class II Devices Event

Event ID64935
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOlympus America Inc.
CityCenter Valley
StatePA
CountryUS
Distribution PatternNationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.
 

Associated Products

Product DescriptionOlympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
Code InfoModel UES-40, all serial numbers prior to 7925334 that have not been upgraded.
ClassificationClass II
Reason for RecallOlympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that some users were exceeding the maximum output time beyond the timeframes specified in the labeling. Exceeding the maximum output time can cause the UES-40 to overheat thereby causing the unit to stop working and produce smoke vapors.
Product Quantity608
Recall NumberZ-1277-2013

Class II Devices Event

Event ID64962
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSymmetry Medical/SSI
CityAntioch
StateTN
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
 

Associated Products

Product DescriptionCodman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
Code Info244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160
ClassificationClass II
Reason for RecallThere is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.
Product Quantity524 boxes of 10
Recall NumberZ-1267-2013

Class II Devices Event

Event ID64988
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedshape Solutions, INC.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
 

Associated Products

Product DescriptionExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
Code InfoLot No. 113011-002
ClassificationClass II
Reason for RecallExpiration date on the patient label and date on the product carton were not the same.
Product Quantity26
Recall NumberZ-1276-2013

Class II Food Event

Event ID65069
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWinn-Dixie Logistics, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternAL, GA, FL, MS, and LA
 

Associated Products

Product DescriptionWinn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz
Code InfoLot # 3690230152 exp 1/15/2014 Lot # 3690230292 exp 1/29/2014 Lot # 3690230582 exp 2/27/2014 Lot # 3690230702 exp 3/11/2014 Lot # 3690230702 exp 3/12/2014 Lot # 3690230842 exp 3/25/2014
ClassificationClass II
Reason for RecallThe product is being recalled as a precaution because it could have levels of "patulin" that exceeds FDA limits.
Product Quantity6,104 pieces
Recall NumberF-1380-2013

Class II Drugs Event

Event ID65077
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionDiazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Code InfoLot 05-585-EV Exp. 05/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity114,000 vials
Recall NumberD-313-2013
Product DescriptionFurosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Code InfoLot 20-564-DK Exp. 02/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity259,050 vials
Recall NumberD-314-2013
Product DescriptionQUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02
Code InfoLot 21-480-EV Exp.12/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity139,200 vials
Recall NumberD-315-2013
Product DescriptionSodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Code InfoLot 23-320-DK and 23-321-DK Exp. 11/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity266,900 vials
Recall NumberD-316-2013

Class III Biologics Event

Event ID32603
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternUS states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.
 

Associated Products

Product DescriptionMicro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*11 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number: 003).
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity2
Recall NumberB-1422-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*26 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSP1-26 Lot Number: 01A
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity1
Recall NumberB-1423-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSP2H Lot Number: 04A and 005
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity2
Recall NumberB-1424-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSP2L Lot Number: 007
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity1
Recall NumberB-1425-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB Only Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSP2LB Lot Number: 004
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity1
Recall NumberB-1426-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP HLA Class I and II ABDR DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSPABDR (Lot Number: 008 and 009) and SSPABDRX (Lot Number: 008 and 009)
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity4
Recall NumberB-1427-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB/DQB1/DPB1 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSPDRQP1 Lot Number: 001
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity1
Recall NumberB-1428-13
Product DescriptionMicro SSP DNA Typing Trays Micro SSP Generic HLA Class I and II DNA Typing Tray - ABDRDQ Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Code InfoCatalog Identification: SSPML02 Lot Number: 003 and 004
ClassificationClass III
Reason for RecallMicro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Product Quantity2
Recall NumberB-1429-13

Class III Biologics Event

Event ID49339
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York and New Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2004692
ClassificationClass III
Reason for RecallBlood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.
Product Quantity1 component
Recall NumberB-1506-13

Class III Devices Event

Event ID53487
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpinal Elements, Inc
CityCarlsbad
StateCA
CountryUS
Distribution PatternDistributed in OH and PA.
 

Associated Products

Product DescriptionMercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080582
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1246-2013
Product DescriptionMercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080583
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1247-2013
Product DescriptionMercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080584
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1248-2013
Product DescriptionMercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080585
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1249-2013
Product DescriptionMercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot number: 080586
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1250-2013
Product DescriptionMercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot number: 080587
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1251-2013
Product DescriptionMercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080588
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1252-2013
Product DescriptionMercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080589
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1253-2013
Product DescriptionMercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot number: 080590
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1254-2013
Product DescriptionMercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080591
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1255-2013
Product DescriptionMercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot number: 080592
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1256-2013
Product DescriptionMercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080593
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1257-2013
Product DescriptionMercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080594
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1258-2013
Product DescriptionMercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080594
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1259-2013
Product DescriptionMercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080596
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1260-2013
Product DescriptionMercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080597
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1261-2013
Product DescriptionMercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080598
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1262-2013
Product DescriptionMercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080599
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1263-2013
Product DescriptionMercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080600
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1264-2013
Product DescriptionMercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080601
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1265-2013
Product DescriptionMercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code InfoLot Number: 080602
ClassificationClass III
Reason for RecallSpinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Product Quantity68 units total
Recall NumberZ-1266-2013

Class III Biologics Event

Event ID64090
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code InfoW045012093999;
ClassificationClass III
Reason for RecallBlood product, with an unacceptably low red cell recovery rate, was distributed.
Product Quantity1
Recall NumberB-1011-13

Class III Biologics Event

Event ID64098
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBio-Blood Components, Inc.
CityGary
StateIN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionSource Plasma
Code Info12GINB4552;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1016-13

Class III Biologics Event

Event ID64119
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityLubbock
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041512052481*;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose medical history screening was not adequately performed, was distributed.
Product Quantity1
Recall NumberB-0409-13

Class III Veterinary Event

Event ID64663
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmProcter & Gamble Co
CityMason
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA & WI. Product was also shipped to Canada.
 

Associated Products

Product DescriptionIams Shakeables Gobble em Up With Turkey for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202
Code InfoUPC 0 19014 61043 3, Lot # 2325419715A 3103, Best By Date April 20, 2014; Lot # 2331419715A 3103, Best By Date April 26, 2014; Lot # 2332419715A 3103, Best By Date April 26, 2014; Lot # 2341419715A 3103, Best By Date May 6, 2014; Lot # 2342419715A 3103, Best By Date May 7, 2014; Lot # 3016419715A 3103, Best By Date June 16, 2014; Lot # 3017419715A 3103, Best By Date June 17, 2014; Lot # 3018419715A 3103, Best By Date June 18, 2014 & Lot # 3046419715A 3103, Best By Date July 15, 2014.
ClassificationClass III
Reason for RecallThe firm was notified via consumer complaints that the product contains mold.
Product Quantity46,813 cs/6/6 oz canisters
Recall NumberV-147-2013
Product DescriptionIams Shakeables Un-baa-lievable With Lamb for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202
Code InfoUPC 0 19014 00024 1, Lot # 2338419715A 3102, Best By Date May 3, 2014
ClassificationClass III
Reason for RecallThe firm was notified via consumer complaints that the product contains mold.
Product Quantity4009cs/6//6 oz canisters
Recall NumberV-148-2013

Class III Biologics Event

Event ID64677
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmInternational Biologics LLC
CityScottsdale
StateAZ
CountryUS
Distribution PatternNevada; Ohio; Texas
 

Associated Products

Product DescriptionBone
Code InfoIBM1259119006; IBM1259119007; IBM1259119008; IBM1259119009; IBM1259119010; IBM1259119011; IBM1259119012; IBM1259119013; IBM1259119014; IBM1259119015; IBM1259119016; IBM1259119017; IBM1259119018; IBM1259119019; IBM1259119020
ClassificationClass III
Reason for RecallHuman tissue allografts were processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
Product Quantity15 allografts
Recall NumberB-1430-13

Class III Drugs Event

Event ID64729
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmL. Perrigo Co.
CityAllegan
StateMI
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLiothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Code Info12K714 exp. 12/13, 12K715 exp. 12/13
ClassificationClass III
Reason for RecallFailed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing.
Product Quantity21,667 bottles
Recall NumberD-318-2013

Class III Biologics Event

Event ID64741
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrtho Clinical Diagnostics Inc
CityRaritan
StateNJ
CountryUS
Distribution PatternMultiple U.S. States
 

Associated Products

Product DescriptionRho(D) Immune Globulin (Human)
Code InfoRVP166A1, RVP167A1, RVP164A1
ClassificationClass III
Reason for RecallRh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed.
Product Quantity3
Recall NumberB-1431-13

Class III Biologics Event

Event ID64799
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUniversity Of Miami Miller School of Medicine Tissue Bank
CityMiami
StateFL
CountryUS
Distribution PatternWisconsin; Florida
 

Associated Products

Product DescriptionBone
Code Info0090330081; 0090330080
ClassificationClass III
Reason for RecallHCT/P allografts, mislabeled with an incorrect expiration date, were distributed.
Product Quantity2 allografts
Recall NumberB-1433-13

Class III Veterinary Event

Event ID64920
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLloyd Inc. of Iowa
CityShenandoah
StateIA
CountryUS
Distribution PatternDistribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.
 

Associated Products

Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.1mg, packaged in 120-ct bottles (NDC 11789-251-10), Lloyd, Shenandoah, IA.
Code InfoLot: VKE29211, Exp date: Jul-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity14,439/120-ct bottles
Recall NumberV-149-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.2 mg, packaged in 120-ct bottles (NDC 11789-252-10), Lloyd, Shenandoah, IA.
Code InfoLot:: KB33411, Exp date: Sep-13; Lot: KB33411A, Exp date: Sep-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity12,387/120-ct bottles
Recall NumberV-150-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.3 mg, packaged in 120-ct bottles (NDC 11789-253-10), Lloyd, Shenandoah, IA.
Code InfoLot:: KA32111, Exp date: Aug-13; Lot: KA32111A, Exp date: Aug-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity12,387/120-ct bottles
Recall NumberV-151-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.4 mg, packaged in 120-ct bottles (NDC 11789-254-10), Lloyd, Shenandoah, IA.
Code InfoLot:: KB33611, Exp date: Sep-13; Lot: KB33611A, Exp date: Sep-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity12,632/120-ct bottles
Recall NumberV-152-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.6 mg, packaged in 120-ct bottles (NDC 11789-256-10), Lloyd, Shenandoah, IA.
Code InfoLot:: KA32511, Exp date: Aug-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity15,024/120-ct bottles
Recall NumberV-153-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.5 mg, packaged in 120-ct bottles (NDC 11789-255-10), Lloyd, Shenandoah, IA.
Code InfoLot:: VKA31311, Exp date: Aug-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity14,669/120-ct bottles
Recall NumberV-154-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.7 mg, packaged in 120-ct bottles (NDC 11789-257-10), Lloyd, Shenandoah, IA.
Code InfoLot:: KD33611, Exp date: Sep-13 and Lot:: KD33611A, Exp date: Sep-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity10,172/120-ct bottles
Recall NumberV-155-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.8 mg, packaged in 120-ct bottles (NDC 11789-258-10), Lloyd, Shenandoah, IA.
Code InfoLot:: VKB30711, Exp date: Aug-13 and Lot:: VKB02412, Exp date: Nov-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity23,717/120-ct bottles
Recall NumberV-156-2013
Product DescriptionLloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 1.0 mg, packaged in 120-ct bottles (NDC 11789-268-10), Lloyd, Shenandoah, IA.
Code InfoLot:: VKF33611, Exp date: Sep-13 and Lot:: VKF33611A, Exp date: Sep-13
ClassificationClass III
Reason for RecallThe product Lot number and/or Expiration Date may be illegible or may be erased.
Product Quantity11,122/120-ct bottles
Recall NumberV-157-2013

Class III Drugs Event

Event ID65004
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionPlavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Code InfoLot # 67JV Exp 08/13
ClassificationClass III
Reason for RecallChemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Product Quantity60 tablets
Recall NumberD-317-2013

Mixed Classification Food Event

Event ID65056
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMaple View Ice Cream
CityHillsborough
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionMaple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Code InfoIndividual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.
ClassificationClass I
Reason for RecallUndeclared allergens: Peanuts, Almond and Soy (soy lecithin and soybean oil).
Product Quantity2,650 pints
Recall NumberF-1377-2013
Product DescriptionMaple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Code InfoIndividual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.
ClassificationClass II
Reason for RecallUndeclared allergens: Wheat and Soy (soybean oil).
Product Quantity
Recall NumberF-1378-2013
Product DescriptionMaple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Code InfoIndividual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.
ClassificationClass II
Reason for RecallUndeclared allergens: Wheat and Soy (soy lecithin).
Product Quantity
Recall NumberF-1379-2013
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