BEUDAMED
    FDA Recall Terminated

    Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.

    Recall: Z-1044-04 · Initiated June 22, 2004

    Recall

    Recall Number
    Z-1044-04
    Event Number
    29397
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    KDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2004
    Posted
    July 20, 2004
    Terminated
    November 3, 2005
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.

    Reason

    Inadequate closure compromising sterility.

    Action

    The recall was initiated by certified letter on 06/22/2004.

    Distribution

    Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.

    Quantity

    5604 units