BEUDAMED
    FDA Recall Terminated

    GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.

    Recall: Z-1314-2008 · Initiated March 7, 2008

    Recall

    Recall Number
    Z-1314-2008
    Event Number
    47210
    Firm
    ConvaTec
    FEI Number
    3011987967
    Product Code
    EXB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 7, 2008
    Posted
    July 2, 2008
    Terminated
    October 21, 2008
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558-2624

    Description

    GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.

    Reason

    Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."

    Action

    Consignees were notified by an Urgent Product Recall letter sent on 3/7/08. The letter instructed users to return any unused affected product to the recalling firm for a credit. For additional information, contact 1-800-422-8811.

    Distribution

    Worldwide Distribution including USA and country of Canada.

    Quantity

    9,299 units