BEUDAMED
    FDA Recall Terminated

    Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558

    Recall: Z-1179-2008 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-1179-2008
    Event Number
    46802
    Firm
    ConvaTec
    FEI Number
    3011987967
    Product Code
    EXB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 14, 2008
    Posted
    May 7, 2008
    Terminated
    October 21, 2008
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558-2624

    Description

    Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558

    Reason

    Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.

    Action

    Consignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.

    Distribution

    Nationwide Distribution.

    Quantity

    3986 market units