BEUDAMED
    FDA Recall Terminated

    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

    Recall: Z-1796-2013 · Initiated June 20, 2013

    Recall

    Recall Number
    Z-1796-2013
    Event Number
    65635
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 20, 2013
    Posted
    July 24, 2013
    Terminated
    June 4, 2015
    Address
    400 Wood Road, Braintree, MA, 02184-2412

    Description

    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

    Reason

    Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

    Action

    Haemonetics sent a Medical Device Correction letter dated June 20, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. The letter instructs customers to discard the current manuals and replace with revised manuals included with the Customer Notification Letter. A Consignee Response Form has been included with the letter, which is to be signed and returned for effectiveness purposes. Follow up will be made to customers who don't return the Response Form. For questions contact TEG Technical Support team at 1-800-438-2834.

    Distribution

    US Nationwide

    Quantity

    1590 devices