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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 40591
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-07-06
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern MO, IL, AL, SC, MI, PR, France

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets. The responsible firm listed on the product label is American Red Cross Blood Services. 11LE27830 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 1 unit B-1127-13
Cryoprecipitated AHF. The responsible firm listed on the product label is American Red Cross Blood Services. 11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84930 11GK84932 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 7 units B-1126-13
Fresh Frozen Plasma. The responsible firm listed on the product label is American Red Cross Blood Services. 11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 5 units B-1125-13
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 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 80 units B-1124-13
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 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 40 units B-1123-13
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 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. 116 units B-1122-13
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