Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Plasma Frozen within 24 hours after Phlebotomy (FP24) |
|---|---|
| Recall Number | B-0532-13 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 54 units |
| Reason For Recall | Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. |
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 |
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