BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1738-2011 · Initiated January 28, 2011

    Recall

    Recall Number
    Z-1738-2011
    Event Number
    57809
    Firm
    Haemoscope Division of Haemonetics Corp
    FEI Number
    2429444
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2011
    Posted
    March 21, 2011
    Terminated
    March 12, 2012
    Address
    6231 W Howard St, Niles, IL, 60714-3403

    Description

    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

    Reason

    Haemonetics has received a report of smoke from the unit with a power supply failure.

    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.

    Distribution

    Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA

    Quantity

    1,155 units