BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0155-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0155-2015
    Event ID
    69412
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coloplast Manufacturing US, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    September 29, 2014
    Classification Date
    October 30, 2014
    Termination Date
    March 10, 2015
    Address
    1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States

    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.

    Code Info

    Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.

    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