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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 49793
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Cleveland
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-08-07
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern OH, NJ, GA, MO, NC, MI, SC, IN, and CA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen within 24 hours after Phlebotomy (FP24) 42FZ62526; 42FG38596; 42FZ31978; 006LV50504; 006LV50477; 006LH16787; 006FY92533; 006LT83833; 006FY93230; 006GV77545; 006GE03248; 006FC59791; 006FC59790; 006GX88824; 006GX88853; 006FE31590; 006FE31591; 006GX88583; 006FR07331; 006FR07309; 006FY91374; 006GX88558; 006FY91468; 006LT84124; 006FY91564; 006FY83209; 006LS18607; 006GP95732; 006FE32997; 006FC60183; 006LH16761; 006LQ04205; 006LT84139; 006FY92525; 006FR07284; 006GT77323; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91322; 006FE30810; 006GT76431; 006GL03267; 006FY91566 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 54 units B-0532-13
Red Blood Cells Leukocytes Reduced Irradiated 006FE32995 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 1 unit B-0531-13
Cryoprecipitate AHF, Pooled 006L16589 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 1 unit B-0530-13
Red Blood Cells 42FG38734 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 1 unit B-0529-13
Plasma Frozen 42FE10144; 42FG38596; 42GX05663; 42CX05665; 42L54010 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 5 units B-0528-13
Red Blood Cells Leukocytes Reduced 42FE10146; 42FG38598; 42L54257; 42GX05663; 42GS32747; 42FE10012; 42FE10015; 42FE10144; 42FE10145; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 42FY87647; 42GX05665; 42L54010; 42L54256; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006LH17884; 006GT77083; 006GE34211; 006LV50477; 006LP45421; 006LQ04192; 006LV50512; 006LV50488; 006LV50506; 006LH17880; 006LY83121; 006LY83089; 006LY83117; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 006FY92834; 006FC59395; 42FW52035; 42FG38596; 42FG38597;42M35638; 42GT24395; 42GS33656; 42GM06234; 42GM06237; 42GM06238; 42W53470; 42GM06233; 42M35638; 006FE32665; 006GV77287; 42FY81647; 42GX05665; 42L54010; 42L54256 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 51 units B-0527-13
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