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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description 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.
Recall Number B-1670-13
Classification Class II
Code Info Catalog number 81000, ALL SERIAL NUMBERS.
Product Distributed Qty 3074 units
Reason For Recall 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.

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 Letter
Distribution Pattern National and global distribution.