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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Recall Number Z-1465-2014
Classification Class II
Code Info Lot Number: RA-27
Product Distributed Qty 37 units
Reason For Recall Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo® Cardiovascular Procedure Kits

Event Detail

Event Id 67925
Product Type Devices
Status Completed
Recalling Firm Terumo Cardiovascular Systems Corp
City Ashland
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern CA