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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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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

Product Detail

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