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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 53630
Product Type Biologics
Status Terminated
Recalling Firm CSL Plasma, Inc.
City Boca Raton
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-08-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Illinois

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 4100357245;4100353872;4100352989;4100349565; 4100342044;4100339263;4100337890;4100335910; 4100333175;4100332154;4100330801;4100329645; 4100327628;4100326150;4100325573;4100323863; 4100323233;4100320460;4100319487;4100318146 4100317254;4100315413;4100314701;4100312805; 4100310298;4100307910;4100306851;4100305683; 4100304613;4100303660;4100302605;4100301245; 4100300337;4100295622;4100294702;4100293336; 4100292077 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 37 Units B-2363-12