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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 65044
Product Type Biologics
Status Ongoing
Recalling Firm Fenwal Inc
City Lake Zurich
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-24
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US (CA, OR, OH, MI)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584 FM13A15027 Class III BLOOD-PACK Units in which the platelet container is incorrectly labeled as "AS-1 Red Blood Cell Adenine-Saline added", were distributed. 16,740 units B-1669-13
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