BEUDAMED
    FDA Recall Terminated

    Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485

    Recall: Z-2616-2010 · Initiated June 8, 2010

    Recall

    Recall Number
    Z-2616-2010
    Event Number
    56413
    Firm
    Terumo Cardiovascular Corporation
    FEI Number
    3000204839
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 8, 2010
    Posted
    September 29, 2010
    Terminated
    February 29, 2012
    Address
    125 Blue Ball Road, Elkton, MD, 21921-5315

    Description

    Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485

    Reason

    Medical device vent port may be occluded and prevent delivery of priming fluid.

    Action

    Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.

    Distribution

    The products were distributed nationwide.

    Quantity

    32 kits