"Product Type","Event ID","Status","Recalling Firm","City","State","Country","Voluntary/Mandated","Initial Firm Notification of Consignee or Public","Distribution Pattern","Recall Number","Classification","Product Description","Code Info","Product Quantity","Reason for Recall","Recall Initiation Date","Report Date"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1422-13","Class III","Micro 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    ","Catalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number:  003).   ","2","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1423-13","Class III","Micro 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    ","Catalog Identification: SSP1-26  Lot Number: 01A    ","1","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1424-13","Class III","Micro 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    ","Catalog Identification: SSP2H  Lot Number: 04A and 005    ","2","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1425-13","Class III","Micro SSP DNA Typing Trays     Micro SSP Generic HLA Class   II DNA Typing Tray      Article Number: SSP_DNAT_PI Rev 18   510(K) Number : BK960062    ","Catalog Identification: SSP2L  Lot Number: 007    ","1","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1426-13","Class III","Micro 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    ","Catalog Identification: SSP2LB  Lot Number: 004    ","1","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1427-13","Class III","Micro 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    ","Catalog Identification: SSPABDR (Lot Number: 008 and 009)    and SSPABDRX (Lot Number: 008 and 009)  ","4","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1428-13","Class III","Micro 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    ","Catalog Identification: SSPDRQP1  Lot Number: 001    ","1","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","32603","Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US 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.","B-1429-13","Class III","Micro 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    ","Catalog Identification: SSPML02  Lot Number: 003 and 004    ","2","Micro 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. ","02/21/2013","05/15/2013"
"Biologics","39504","Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","Nebraska; Pennsylvania;California","B-1097-13","Class II","Red Blood Cells Leukocytes Reduced ","09GV13749; 09GV14552; 09GV15492 ","3 Units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.","12/10/2004","05/15/2013"
"Biologics","39897","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1134-13","Class II","Red Blood Cells Leukocytes Reduced ","20LY55510 , 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. ","60 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.","03/04/2005","05/15/2013"
"Biologics","39897","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1135-13","Class II","Fresh Frozen Plasma ","20lS22585 , 20LS22487 , 20LS22490 , 20LS22594 , 20LS22622 , 20LS22794 , 20LS22784 , 20LS22789 , 20LS22800 , 20LS22801 , 20LS22808 , 20LS22744 , 20LY56070, 20LS22797, 20LS22792, 20LS22357, 20LY56098, 20LS22352, 20LS22804, 20LS22354, 20LY56084, 20LY56087, 20LC72098, 20LS22785. ","24 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.","03/04/2005","05/15/2013"
"Biologics","39897","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1136-13","Class II","Red Blood Cells Leukocytes Reduced Washed ","20LS22919. ","1 unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.","03/04/2005","05/15/2013"
"Biologics","39897","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1137-13","Class II","Plasma Frozen ","20LS22612, 20LS22562, 20LY56192.   ","3 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.","03/04/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1122-13","Class II","Red Blood Cells Leukocytes Reduced.  The responsible firm listed on the product label is American Red Cross Blood Services. ","11KC13068   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        ","116 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1123-13","Class II","Plasma Frozen.  The responsible firm listed on the product label is American Red Cross Blood Services. ","11LE26225   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     ","40 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1124-13","Class II","Red Blood Cells.  The responsible firm listed on the product label is American Red Cross Blood Services. ","11LC92381   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     ","80 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1125-13","Class II","Fresh Frozen Plasma.  The responsible firm listed on the product label is American Red Cross Blood Services. ","11LZ28895   11GP17262    11GP17265    11GP17267    11GP17268     ","5 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1126-13","Class II","Cryoprecipitated AHF.    The responsible firm listed on the product label is American Red Cross Blood Services. ","11GK84919   11GK84923    11GK84925    11GK84926    11GK84928    11GK84930    11GK84932     ","7 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","40591","Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1127-13","Class II","Platelets. The responsible firm listed on the product label is American Red Cross Blood Services. ","11LE27830    ","1 unit","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","07/06/2005","05/15/2013"
"Biologics","44351","Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","South Carolina, California","B-0965-13","Class II","Red Blood Cells Leukocytes Reduced ","36Q78865 ","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.","01/10/2007","05/15/2013"
"Biologics","44351","Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","South Carolina, California","B-0966-13","Class II","Blood and Blood Products for Reprocessing ","36Q78865 ","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.","01/10/2007","05/15/2013"
"Biologics","45449","Terminated","Cangene Corporation - Rh Plasma Center","Winnipeg","MB","CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada","B-1062-13","Class II","Source Plasma ","RH0019179 ","1 unit","Blood product, quality control and distribution/required testing not performed for HIV/HCV Nucleic Acid Test (NAT), was distributed.","05/24/2007","05/15/2013"
"Biologics","48527","Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1061-13","Class II","Platelets Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3. ","9912770 (Part A); 9912770(Part B); 9912770(Part C)  ","3 units","Blood products, platelet pheresis leukocytes reduced with an unacceptable pH, were distributed. ","12/11/2007","05/15/2013"
"Biologics","48914","Terminated","BioLife Plasma Services L.P.","Cedar Rapids","IA","US","Voluntary: Firm Initiated","FAX","Austria","B-1092-13","Class II","Source Plasma ","08CIAB7249 ","1 Unit","Blood products, collected from a donor who was not asked vCJD travel questions, was distributed.","05/21/2008","05/15/2013"
"Biologics","49253","Terminated","Florida Blood Services, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida,  Switzerland.","B-1057-13","Class II","Cryoprecipitate AHF ","4411171 ","1 unit","Blood products, collected from a donor who provided a different last name,  were distributed.","02/15/2008","05/15/2013"
"Biologics","49339","Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York and New Jersey","B-1506-13","Class III","Red Blood Cells Leukocytes Reduced ","2004692 ","1 component ","Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.","08/08/2008","05/15/2013"
"Biologics","49633","Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria.","B-1056-13","Class II","Blood and Blood Products for Reprocessing Recovered Plasma Cryoprecipitate Reduced. ","5699436 ","1 unit","Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","07/08/2008","05/15/2013"
"Biologics","50028","Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1090-13","Class II","Fresh Frozen Plasma ","574252 ","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","08/27/2008","05/15/2013"
"Biologics","50028","Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1091-13","Class II","Recovered Plasma Frozen within 24 Hour of Phlebotomy (Blood and Blood Products for Reprocessing). ","5575117; 5266741 ","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","08/27/2008","05/15/2013"
"Biologics","50638","Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1089-13","Class II","Source Plasma ","366051639;366053393;366053758;366054269;366055108;366055486;366057062;366058924;366059301;366073292;366073628;366077496 ","12 units","Blood products, collected from a donor who was permanently deferred, were distributed.","07/17/2008","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1246-2013","Class III","Mercury 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.  ","Lot Number: 080582 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1247-2013","Class III","Mercury 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.     ","Lot Number: 080583 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1248-2013","Class III","Mercury 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.  ","Lot Number: 080584 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1249-2013","Class III","Mercury 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.     ","Lot Number: 080585 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1250-2013","Class III","Mercury 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.  ","Lot number: 080586 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1251-2013","Class III","Mercury 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.  ","Lot number: 080587 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1252-2013","Class III","Mercury 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.     ","Lot Number: 080588 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1253-2013","Class III","Mercury 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.  ","Lot Number: 080589 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1254-2013","Class III","Mercury 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.     ","Lot number: 080590 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1255-2013","Class III","Mercury 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.        ","Lot Number: 080591 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1256-2013","Class III","Mercury 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.        ","Lot number: 080592 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1257-2013","Class III","Mercury 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.  ","Lot Number: 080593 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1258-2013","Class III","Mercury 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.  ","Lot Number: 080594 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1259-2013","Class III","Mercury 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.  ","Lot Number: 080594 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1260-2013","Class III","Mercury 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.  ","Lot Number: 080596 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1261-2013","Class III","Mercury 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.     ","Lot Number: 080597 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1262-2013","Class III","Mercury 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.     ","Lot Number: 080598 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1263-2013","Class III","Mercury 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.  ","Lot Number: 080599 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1264-2013","Class III","Mercury 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.     ","Lot Number: 080600 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1265-2013","Class III","Mercury 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.     ","Lot Number: 080601 ","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","53487","Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1266-2013","Class III","Mercury 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.  ","Lot Number: 080602 ","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.","04/17/2009","05/15/2013"
"Devices","60555","Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of:  IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.","Z-1216-2013","Class II","KARL 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. ","The 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. ","15 units","The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.   ","08/16/2012","05/15/2013"
"Biologics","64051","Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-1007-13","Class II","Plasma Frozen within 24 hours (FP24) ","22GM75439;  ","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","11/21/2012","05/15/2013"
"Biologics","64052","Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-1043-13","Class II","Red Blood Cells Leukocytes Reduced ","W045212014473;  ","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.","12/21/2012","05/15/2013"
"Biologics","64053","Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1006-13","Class II","Blood and Blood Products for Reprocessing ","M169858;  ","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","10/02/2012","05/15/2013"
"Biologics","64060","Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1005-13","Class II","Source Plasma ","3580167569; 3580167563; 3580167559; 3580167571; 3580167556; 3580167561; 3580167570; 3580168680; 3580168682; 3580168671; 3580168689; 3580168669; 3580168688; 3580168687;  ","14","Blood products, which were not tested for viral markers, were distributed.","09/21/2012","05/15/2013"
"Biologics","64087","Terminated","The Children's Hospital Assoc. Transfusion Medicine Services","Aurora","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-0408-13","Class II","Whole Blood ","W140512443683;  ","1","Blood product, collected from an autologous donor but incorrectly labeled as a homologous unit, was distributed.","12/04/2012","05/15/2013"
"Biologics","64088","Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-1008-13","Class II","Platelets Pheresis Leukocytes Reduced ","W227712044243; W227712044243;  ","2","Blood products, with pH below the acceptable level, were distributed.","12/10/2012","05/15/2013"
"Biologics","64089","Terminated","Hemacare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-1010-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated ","W313712015322;  ","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.","12/17/2012","05/15/2013"
"Biologics","64090","Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1011-13","Class III","Red Blood Cells Leukocytes Reduced Washed ","W045012093999;  ","1","Blood product, with an unacceptably low red cell recovery rate, was distributed.","11/26/2012","05/15/2013"
"Biologics","64093","Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1012-13","Class II","Red Blood Cells Leukocytes Reduced ","P60990;  ","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","01/04/2013","05/15/2013"
"Biologics","64094","Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","Oregon","B-1013-13","Class II","Red Blood Cells Leukocytes Reduced ","W137512111712; W137512107157;  ","2","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed","01/03/2013","05/15/2013"
"Biologics","64095","Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1014-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W04211091240; W04211091240;  ","2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","12/11/2012","05/15/2013"
"Biologics","64096","Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1015-13","Class II","Source Plasma ","3270201511; 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;  ","29","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.","11/30/2012","05/15/2013"
"Biologics","64098","Terminated","Bio-Blood Components, Inc.","Gary","IN","US","Voluntary: Firm Initiated","E-Mail","Tennessee","B-1016-13","Class III","Source Plasma ","12GINB4552;  ","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","11/30/2012","05/15/2013"
"Biologics","64119","Terminated","Blood Systems, Inc. dba United Blood Services","Lubbock","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0409-13","Class III","Red Blood Cells Leukocytes Reduced ","W041512052481*;  ","1","Blood product, collected from a donor whose medical history screening  was not adequately performed, was distributed.                     ","12/07/2012","05/15/2013"
"Devices","64444","Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, GA, NJ, and TX.","Z-1215-2013","Class II","BD 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.  ","Lot No./Exp. Date: 2237214 / 2013-10-31. ","77 kits","Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.","02/08/2013","05/15/2013"
"Veterinary","64663","Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product 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.","V-147-2013","Class III","Iams Shakeables Gobble em Up With Turkey for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202  ","UPC 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. ","46,813 cs/6/6 oz canisters","The firm was notified via consumer complaints that the product contains mold.","03/11/2013","05/15/2013"
"Veterinary","64663","Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product 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.","V-148-2013","Class III","Iams Shakeables  Un-baa-lievable  With Lamb for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202  ","UPC 0 19014 00024 1, Lot # 2338419715A 3102, Best By Date May 3, 2014 ","4009cs/6//6 oz canisters","The firm was notified via consumer complaints that the product contains mold.","03/11/2013","05/15/2013"
"Biologics","64677","Terminated","International Biologics LLC","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Nevada; Ohio; Texas","B-1430-13","Class III","Bone ","IBM1259119006; IBM1259119007; IBM1259119008; IBM1259119009; IBM1259119010; IBM1259119011; IBM1259119012; IBM1259119013; IBM1259119014; IBM1259119015; IBM1259119016; IBM1259119017; IBM1259119018; IBM1259119019; IBM1259119020 ","15 allografts","Human 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.","03/12/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1218-2013","Class II","Stryker 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.    ","Manufacturer Part Number: 250-070-403 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1219-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-403 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1220-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-404. ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1221-2013","Class II","Stryker 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. ","Manufacturer Part Number:250-070-407 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1222-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-408. ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1223-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-409 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1224-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-411 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1225-2013","Class II","Stryker Irrigator Reusable Tips:  5mm X 32cm Aspiration Needle Tip.      Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery. ","Manufacturer Part Number: 250-070-437 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1226-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-471 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1227-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-472 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1228-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-473 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1229-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-482 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1230-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-483 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1231-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-484 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1232-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-487 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1233-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-488 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1234-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-488s2 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1235-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-489 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1236-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-490 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64682","Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1237-2013","Class II","Stryker 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. ","Manufacturer Part Number: 250-070-491 ","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C.","03/27/2013","05/15/2013"
"Devices","64696","Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of  Puerto Rico, Brazil, Canada and Columbia.","Z-1268-2013","Class II","A) 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.    ","A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155;      B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016  ","A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.","03/28/2013","05/15/2013"
"Devices","64696","Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of  Puerto Rico, Brazil, Canada and Columbia.","Z-1269-2013","Class II","A) 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. ","A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057   ","A) Product Code 2N3371: 228,200 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.","03/28/2013","05/15/2013"
"Devices","64696","Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of  Puerto Rico, Brazil, Canada and Columbia.","Z-1270-2013","Class II","A) 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.    ","A) 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 ","A) 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","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.","03/28/2013","05/15/2013"
"Devices","64696","Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of  Puerto Rico, Brazil, Canada and Columbia.","Z-1271-2013","Class II","A) 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.    ","A) 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   ","A) Product Code 2N8371: 513,000 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.","03/28/2013","05/15/2013"
"Devices","64699","Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-1272-2013","Class II","Siemens 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. ","All 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.     ","21,608 boxes = 432,160 panels","Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.","03/06/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1239-2013","Class II","Wallace 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. ","Lot Codes:  2000099   2044001   2044005   2117201   2117202   2120953   2138832   2138833   2161554   2304181   2304182   2304199   2305239   2305240   2308138   2313278   2332537   2336956   2336957   2341409   2341410   2344790                                                              ","22380 units  ","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1240-2013","Class II","Wallace 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. ","Lot 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    ","59089 units","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1241-2013","Class II","Wallace 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. "," Lot Codes:  2000102   2138834   2143444   2147484   2152583   2152584   2304183   2305244   2336960    ","11550 units","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1242-2013","Class II","Wallace 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. ","Lot 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          ","37620 units","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1243-2013","Class II","Wallace 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. ","Lot Code: 2000103, 2025752, 2161556, 2165854, 2170929,   2304190, 2363603 ","4910 units","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Devices","64705","Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide 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).","Z-1244-2013","Class II","Wallace 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. ","Lot codes:   2000098   2025748   2041152   2332539   2350024    ","800 units","Unable to pass catheter through outer sheath during embryo transfer","03/28/2013","05/15/2013"
"Drugs","64729","Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Letter","Nationwide","D-318-2013","Class III","Liothyronine Sodium Tablets, USP,  5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc.,  Minneapolis, MN 55427,  NDC 0574-0220-01, ","12K714 exp. 12/13, 12K715 exp. 12/13 ","21,667 bottles","Failed 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.  ","03/12/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1193-2013","Class I","Presource PBDS, Gyn Laparoscopy Kit, Circulator ","Catalog Number: PB24LSNPC01; Lots: 152737, 159630, 168459, 176674, 187217, 197319, 840618   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1194-2013","Class I","A) Presource PBDS, Lap Chole, Kit, Clean Up;   B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit ","A) 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 ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1195-2013","Class I","Presource PBDS, General Laparoscopy, Kit, Circulator ","Catalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1196-2013","Class I","Presource PBDS, Major Abdominal, Kit, Circulator ","Catalog Number: PG24MANPC01; Lots: 840143, 857320, 871000, 882315, 900599, 928133, 942238, 952387, 964048   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1197-2013","Class I","Presource PBDS, Knee Arthroscopy, Kit, Circulator ","Catalog Number: PO24AKNPC01; Lots: 851288, 877594, 901672, 917786, 948443, 972424   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1198-2013","Class I","Presource PBDS, Extremity, Kit, Circulator ","Catalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317      ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1199-2013","Class I","Presource PBDS, Hand, Kit, Circulator ","Catalog Number: PO24HKGWG01; Lots: 856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1200-2013","Class I","Presource PBDS, Shoulder Arthroscopy, Kit, Circulator ","Catalog Number: PO24SAGWF01; Lots: 847129, 877843, 905183, 931801, 935180, 946651, 957422, 969585   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1201-2013","Class I","Presource PBDS, Shoulder Procedure, Kit, Circulator ","Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1202-2013","Class I","Presource PBDS, Total Hip, Kit, Circulator ","Catalog Number: PO24THGWG01; Lots: 966051, 970753   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1203-2013","Class I","Presource PBDS, Total Joint, Kit, Circulator ","Catalog Number: PO24TJNPC01; Lots: 843134, 851291, 875033, 893475, 911751, 914529, 928726, 948543, 968125, ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1204-2013","Class I","Presource PBDS, Total Knee, Kit, Circulator ","Catalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208   ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1205-2013","Class I","Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit ","Catalog Number:PZ23ANBUG; Lot: 200710 ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Devices","64736","Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1206-2013","Class I","Presource PBDS, Knee Arthroscopy, Kit, Circulator ","Catalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782 ","4,571 Kits total","Various 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.","03/26/2013","05/15/2013"
"Biologics","64741","Terminated","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-1431-13","Class III","Rho(D) Immune Globulin (Human) ","RVP166A1, RVP167A1,  RVP164A1 ","3","Rh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed. ","02/22/2013","05/15/2013"
"Biologics","64767","Terminated","North Carolina Eye Bank, Inc. (The)","Winston Salem","NC","US","Voluntary: Firm Initiated","Telephone","Texas","B-1432-13","Class II","Cornea ","04871302 ","1 Cornea","Human 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. ","03/11/2013","05/15/2013"
"Devices","64771","Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI","Z-1238-2013","Class II","Synthes 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. ","All 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. ","417","The 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.","02/22/2013","05/15/2013"
"Biologics","64773","Ongoing","Siemens Healthcare Diagnostics Inc.","Berkeley","CA","US","Voluntary: Firm Initiated","Letter","US 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","B-1448-13","Class II","MicroCel 500 Buffer Chamber     Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 ","Catalog number 10312319/VG 42115   ","1","MicroCel 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. ","03/28/2013","05/15/2013"
"Biologics","64773","Ongoing","Siemens Healthcare Diagnostics Inc.","Berkeley","CA","US","Voluntary: Firm Initiated","Letter","US 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","B-1449-13","Class II","MicroCel 300 Buffer Chamber     Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 ","Catalog number 10319937/ VG 42044 ","1","MicroCel 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. ","03/28/2013","05/15/2013"
"Biologics","64799","Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Wisconsin; Florida","B-1433-13","Class III","Bone ","0090330081; 0090330080 ","2 allografts","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ","11/12/2010","05/15/2013"
"Biologics","64815","Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-1447-13","Class II","Red Blood Cells Leukocytes Reduced ","003LH34364 ","1 unit","Blood product, misbranded as Jkb negative, and subsequently determined to be JKb positive, was distributed. ","02/12/2013","05/15/2013"
"Devices","64876","Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide Distribution","Z-1245-2013","Class I","FreeStyle 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.  ","Part Numbers:  71142-70   71143-70   71145-70   71150-70:   All serial and lot numbers. ","335,273 meters in the US, and 607,137 internationally ","AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.","04/15/2013","05/15/2013"
"Devices","64898","Ongoing","Cypress Medical Products LLC","Mchenry","IL","US","Voluntary: Firm Initiated","E-Mail","US Distribution to the state of VA only.","Z-1273-2013","Class II","Cypress 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. ","Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box. ","150 Cases (75,000 Units)","Cypress 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.","04/15/2013","05/15/2013"
"Devices","64913","Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide 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.","Z-1278-2013","Class II","DePuy 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.  ","Lot number:13A01    ","27 units","Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. ","04/15/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-149-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.1mg, packaged in 120-ct bottles (NDC 11789-251-10), Lloyd, Shenandoah, IA.   ","Lot: VKE29211, Exp date: Jul-13 ","14,439/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-150-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.2 mg, packaged in 120-ct bottles (NDC 11789-252-10), Lloyd, Shenandoah, IA.   ","Lot:: KB33411, Exp date: Sep-13; Lot: KB33411A, Exp date: Sep-13 ","12,387/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-151-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.3 mg, packaged in 120-ct bottles (NDC 11789-253-10), Lloyd, Shenandoah, IA.   ","Lot:: KA32111, Exp date: Aug-13; Lot: KA32111A, Exp date: Aug-13 ","12,387/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-152-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.4 mg, packaged in 120-ct bottles (NDC 11789-254-10), Lloyd, Shenandoah, IA.   ","Lot:: KB33611, Exp date: Sep-13; Lot:  KB33611A, Exp date: Sep-13 ","12,632/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-153-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.6 mg, packaged in 120-ct bottles (NDC 11789-256-10), Lloyd, Shenandoah, IA.   ","Lot:: KA32511, Exp date: Aug-13 ","15,024/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-154-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.5 mg, packaged in 120-ct bottles (NDC 11789-255-10), Lloyd, Shenandoah, IA.   ","Lot:: VKA31311, Exp date: Aug-13 ","14,669/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-155-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.7 mg, packaged in 120-ct bottles (NDC 11789-257-10), Lloyd, Shenandoah, IA.   ","Lot:: KD33611, Exp date: Sep-13 and Lot:: KD33611A, Exp date: Sep-13  ","10,172/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-156-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.8 mg, packaged in 120-ct bottles (NDC 11789-258-10), Lloyd, Shenandoah, IA.   ","Lot:: VKB30711, Exp date: Aug-13 and Lot:: VKB02412, Exp date: Nov-13  ","23,717/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Veterinary","64920","Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel.  Specific distribution will be reported.","V-157-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 1.0 mg, packaged in 120-ct bottles (NDC 11789-268-10), Lloyd, Shenandoah, IA.   ","Lot:: VKF33611, Exp date: Sep-13 and Lot:: VKF33611A, Exp date: Sep-13  ","11,122/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.","04/04/2013","05/15/2013"
"Devices","64935","Ongoing","Olympus America Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Nationwide 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.","Z-1277-2013","Class II","Olympus 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. ","Model UES-40, all serial numbers prior to 7925334 that have not been upgraded. ","608","Olympus 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.  ","11/10/2009","05/15/2013"
"Devices","64962","Ongoing","Symmetry Medical/SSI","Antioch","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to  Belgium, Canada, Germany, UK","Z-1267-2013","Class II","Codman(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 ","244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160 ","524 boxes of 10","There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.","04/10/2013","05/15/2013"
"Devices","64988","Ongoing","Medshape Solutions, INC.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.","Z-1276-2013","Class II","ExoShape 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. ","Lot No. 113011-002 ","26","Expiration date on the patient label and date on the product carton were not the same.","04/04/2013","05/15/2013"
"Drugs","65004","Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","NC","D-317-2013","Class III","Plavix 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. ","Lot # 67JV Exp 08/13 ","60 tablets","Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).","02/08/2011","05/15/2013"
"Food/Cosmetics","65056","Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1377-2013","Class I","Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. ","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. ","2,650 pints","Undeclared allergens: Peanuts, Almond and Soy (soy lecithin and soybean oil).","04/25/2013","05/15/2013"
"Food/Cosmetics","65056","Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1378-2013","Class II","Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. ","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. ","","Undeclared allergens: Wheat and Soy (soybean oil).","04/25/2013","05/15/2013"
"Food/Cosmetics","65056","Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1379-2013","Class II","Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. ","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. ","","Undeclared allergens: Wheat and Soy (soy lecithin).","04/25/2013","05/15/2013"
"Food/Cosmetics","65069","Ongoing","Winn-Dixie Logistics, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","AL, GA, FL, MS, and LA","F-1380-2013","Class II","Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz ","Lot # 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 ","6,104 pieces","The product is being recalled as a precaution because it could have levels of ''patulin'' that exceeds FDA limits.","04/11/2013","05/15/2013"
"Drugs","65077","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-313-2013","Class II","Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 ","Lot 05-585-EV Exp. 05/13 ","114,000 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.","02/26/2013","05/15/2013"
"Drugs","65077","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-314-2013","Class II","Furosemide 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 ","Lot 20-564-DK Exp. 02/14 ","259,050 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.","02/26/2013","05/15/2013"
"Drugs","65077","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-315-2013","Class II","QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA,  , NDC 0409-6629-02 ","Lot 21-480-EV Exp.12/13 ","139,200 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.","02/26/2013","05/15/2013"
"Drugs","65077","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-316-2013","Class II","Sodium 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 ","Lot 23-320-DK and 23-321-DK  Exp. 11/14 ","266,900 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.","02/26/2013","05/15/2013"