TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
FDA Recall Z-1738-2011 · Posted 2011-03-21
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Recalling FirmHaemoscope Division of Haemonetics Corp
Recall StatusTerminated
Product CodeJPA
Date Initiated2011-01-28
Date Terminated2012-03-12
Product Quantity1,155 units
Reason for Recall
Haemonetics has received a report of smoke from the unit with a power supply failure.
Firm Action
Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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