BEUDAMED
    FDA Recall Terminated

    Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.

    Recall: Z-0065-06 · Initiated June 6, 2005

    Recall

    Recall Number
    Z-0065-06
    Event Number
    32667
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    GWG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2005
    Posted
    October 21, 2005
    Terminated
    October 10, 2006
    Address
    6830 Meadowridge Ct, Alpharetta, GA, 30005-2202

    Description

    Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.

    Reason

    The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.

    Action

    A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.

    Distribution

    AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI

    Quantity

    3180 units