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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Recall Number Z-1796-2013
Classification Class II
Code Info Per recall strategy.
Product Distributed Qty 1590 devices
Reason For Recall Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

Event Detail

Event Id 65635
Product Type Devices
Status Ongoing
Recalling Firm Haemonetics Corporation
City Braintree
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide
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