BEUDAMED
    FDA Recall Terminated

    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

    Recall: Z-0073-2011 · Initiated September 17, 2010

    Recall

    Recall Number
    Z-0073-2011
    Event Number
    56789
    Firm
    Convatec Inc.
    FEI Number
    3011987967
    Product Code
    EZQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 17, 2010
    Posted
    October 18, 2010
    Terminated
    October 19, 2010
    Address
    200 Headquarters Park Drive, Skillman, NJ, 08558-2600

    Description

    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

    Reason

    Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.

    Action

    ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product, For questions call (908) 904-2675.

    Distribution

    USA, including IL

    Quantity

    1 case (20 market units)