BEUDAMED
    FDA Recall Terminated

    SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

    Recall: Z-1134-2022 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1134-2022
    Event Number
    90041
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    EXE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2022
    Terminated
    March 4, 2026
    Address
    7815 National Service Rd, Ste 600, Greensboro, NC, 27409-9403

    Description

    SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

    Reason

    Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

    Action

    The consignee recall notification was sent out via the United Pacel Service on 04/22/2022. The letter instructs the consignee to not use the product and complete the recall response form. The consignee should call the toll-free number to arrange a return.

    Distribution

    Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.

    Quantity

    600 market units