BEUDAMED
    FDA Recall Terminated

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034.

    Recall: Z-1264-03 · Initiated September 3, 2003

    Recall

    Recall Number
    Z-1264-03
    Event Number
    27162
    Firm
    International Surgical Supply, Inc.
    FEI Number
    3003175501
    Product Code
    KDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2003
    Posted
    September 23, 2003
    Terminated
    May 6, 2012
    Address
    8585 NW 72nd St., Miami, FL, 33166

    Description

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034.

    Reason

    Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.

    Action

    The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level.

    Distribution

    Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee.

    Quantity

    6 boxes of 6 each