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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 49993
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 2008-08-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Illinois, Switzerland, Germany

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 4150162098;4150159365;4150158968;4150157895 4150157508;4150154891;4150153300;4150150738 4150149785;4150149203;4150147948;4150147223; 4150146605;4150145206;4150142055;4150141380 4150139234;4150138581;4150135674;4150135265 4150131794;4150131382;4150126722;4150126413 4150124573;4150124379;4150122978;4150122592; 4150120868;4150120657;4150119094;4150118448 4150117306;4150117012;4150112756;4150112283 4150109774 Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. 37 units B-2021-12