BEUDAMED
    FDA Recall Terminated

    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

    Recall: Z-0155-2015 · Initiated September 29, 2014

    Recall

    Recall Number
    Z-0155-2015
    Event Number
    69412
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    NNW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 29, 2014
    Posted
    October 30, 2014
    Terminated
    March 10, 2015
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

    Reason

    Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

    Action

    Consignees were sent a Coloplast "Recall Voluntary Notification " letter on 9-30-2014. The letter described the problem and the product affected by the recall. Requested consignees to complete the attached Acknowledgement Form and return to Coloplast or contact Coloplast Customer Service at 800-533-0464 to communicate the status of any product in their possession. If the product was distributed, they advised consignees to contact customers immediately and advise them of the recall and have them return the product to them. For questions they can contact Coloplast at Customer Service at 800-533-0464.

    Distribution

    Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.

    Quantity

    217,540