BEUDAMED
    FDA Recall Open, Classified

    DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

    Recall: Z-2614-2021 · Initiated August 20, 2021

    Recall

    Recall Number
    Z-2614-2021
    Event Number
    88557
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    NAD
    Status
    Open, Classified
    Root Cause
    Environmental control
    Initiated
    August 20, 2021
    Address
    7815 National Service Rd, Ste 600, Greensboro, NC, 27409-9403

    Description

    DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

    Reason

    Primary packaging labeling may be incorrect.

    Action

    Consignees are notified of the recall via email and letter delivered via UPS. The recalling firm identifies Tier 1 customers as direct consignees and Tier 2 customers and those who receive product from Tier 1 customers. Impacted customers that identify affected product within their inventory are to arrange for return of product through third party Sedgwick.

    Distribution

    Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

    Quantity

    170 packs