BEUDAMED
    FDA Recall Terminated

    IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.

    Recall: Z-0273-2012 · Initiated October 5, 2011

    Recall

    Recall Number
    Z-0273-2012
    Event Number
    60123
    Firm
    International Biophysics Corp
    FEI Number
    1000117854
    Product Code
    DTS
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    October 5, 2011
    Posted
    November 23, 2011
    Terminated
    March 23, 2012
    Address
    2101-2 E Saint Elmo, Ste 275, Austin, TX, 78744

    Description

    IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.

    Reason

    Potential for the sterility to be compromised.

    Action

    International Biophysics Corp. sent a" Medical Device Recall Notice" dated October 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use of the product in the referenced lot number should cease immediately. Customers were asked to follow the instructions in the letter to return the affected product. If you have any further questions please call (512) 814-0070.

    Distribution

    Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX

    Quantity

    1200 units