BEUDAMED
    FDA Recall Open, Classified

    DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

    Recall: Z-2519-2021 · Initiated August 9, 2021

    Recall

    Recall Number
    Z-2519-2021
    Event Number
    88460
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    NAD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 9, 2021
    Address
    7815 National Service Rd, Ste 600, Greensboro, NC, 27409-9403

    Description

    DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

    Reason

    There is a potential for open seals which can compromise sterility.

    Action

    Customer notification was made via email and via UPS letter. Distributors are asked to stop distributing and quarantine all recalled lots. All customers are notified that a Recall Response Form is to be completed and returned to the recalling firm. All impacted product is to be returned via third party Sedgwick, Indianapolis, IN. If product was further distributed, the customer shall forward the recall notification letter and ask subaccounts to follow the recall instructions.

    Distribution

    International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.

    Quantity

    2,734,830 units