BEUDAMED
    FDA Recall Terminated

    IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.

    Recall: Z-1222-06 · Initiated August 16, 2005

    Recall

    Recall Number
    Z-1222-06
    Event Number
    35703
    Firm
    International Biophysics Corp
    FEI Number
    1000117854
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 16, 2005
    Posted
    July 12, 2006
    Terminated
    July 17, 2006
    Address
    2101-2 E Saint Elmo, Ste 275, Austin, TX, 78744

    Description

    IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.

    Reason

    Tyvek pouches containing device labeled as sterile have defective seals.

    Action

    Firm notified customer via telephone on 08/16/05.

    Distribution

    Product distributed to one hospital located in FL.

    Quantity

    179 units.