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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Source Plasma
Recall Number B-1100-12
Classification Class II
Code Info 0650408894; 0650408560; 0650408033; 0650407608; 0650395167; 0650394845; 0650394191; 0650393836; 0650393124; 0650392894; 0650392008; 0650391643; 0650390956; 0650390627; 0650390114; 0650389762; 0650389229; 0650388641; 0650387778; 0650387219; 0650386749; 0650385836; 0650385151; 0650384726; 0650383924; 0650383176; 0650382994; 0650382393; 0650381850; 0650381296; 0650380871; 0650380501; 0650380058; 0650379600; 0650379146; 0650370924; 0650370636; 0650369893; 0650369586; 0650368902; 0650368182; 0650367515; 0650367082; 0650366309; 0650365927; 0650365317; 0650364503
Product Distributed Qty 47 units
Reason For Recall Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

Event Detail

Event Id 49718
Product Type Biologics
Status Terminated
Recalling Firm ZLB Bioplasma Services
City Boca Raton
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-08-11
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern NC
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