BEUDAMED
    FDA Recall Terminated

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile

    Recall: Z-2749-2015 · Initiated July 19, 2015

    Recall

    Recall Number
    Z-2749-2015
    Event Number
    71880
    Firm
    Elcam Medical, Inc.
    FEI Number
    3003649401
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 19, 2015
    Posted
    September 10, 2015
    Terminated
    September 18, 2017
    Address
    2 University Plz, Ste 620, Hackensack, NJ, 07601-6224

    Description

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile

    Reason

    Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

    Action

    Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.

    Distribution

    Texas, New Mexico and Pennsylvania

    Quantity

    248,100