BEUDAMED
    FDA Recall Terminated

    Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011

    Recall: Z-0962-03 · Initiated June 6, 2003

    Recall

    Recall Number
    Z-0962-03
    Event Number
    26475
    Firm
    MedAmicus, Inc
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2003
    Posted
    July 2, 2003
    Terminated
    July 2, 2004
    Address
    15301 Highway 55 West, Plymouth, MN, 55447

    Description

    Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011

    Reason

    Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

    Action

    The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.

    Distribution

    The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.

    Quantity

    20 units