BEUDAMED
    FDA Recall Terminated

    Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.

    Recall: Z-0371-2008 · Initiated October 18, 2007

    Recall

    Recall Number
    Z-0371-2008
    Event Number
    44972
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    October 18, 2007
    Posted
    December 11, 2007
    Terminated
    July 18, 2008
    Address
    104 Windsor Center Dr, East Windsor, NJ, 08520

    Description

    Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.

    Reason

    Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

    Action

    Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.

    Distribution

    Worldwide Distribution- including USA and country of Canada.