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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 64890
Product Type Biologics
Status Ongoing
Recalling Firm Terumo Bct
City Lakewood
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern National and global distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Trima Accel Automated Blood Component Collection System, catalog number 81000, all serial numbers, with software versions prior to 5.1.9 and 6.0.6. Catalog number 81000, ALL SERIAL NUMBERS. Class II Terumo BCT's Trima Accel systems, with a potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system, were distributed. 3074 units B-1670-13