BEUDAMED
    FDA Recall Terminated

    INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.

    Recall: Z-2989-2011 · Initiated July 1, 2011

    Recall

    Recall Number
    Z-2989-2011
    Event Number
    59362
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    JAD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 1, 2011
    Posted
    August 10, 2011
    Terminated
    October 13, 2011
    Address
    5160 Hacienda Dr, Dublin, CA, 94568-7562

    Description

    INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.

    Reason

    Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,

    Action

    Carl Zeiss Meditec, Inc. sent an "Important Field Correction Action" letter dated July 13, 2011 to all affected customers. The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844.

    Distribution

    Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.

    Quantity

    8 boxes of 10 sterile packages.