BEUDAMED
    FDA Recall Open, Classified

    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

    Recall: Z-0190-2023 · Initiated September 28, 2022

    Recall

    Recall Number
    Z-0190-2023
    Event Number
    90955
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    IME
    Status
    Open, Classified
    Root Cause
    Pending
    Initiated
    September 28, 2022
    Posted
    November 7, 2022
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

    Reason

    Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

    Action

    Cardinal Health sent an URGENT:MEDICAL DEVICE PRODUCT CORRECTION on 10/03/2022 by overnight mail. The notice explained the issue and requested the following: "Actions Required: 1. COMMUNICATE with all personnel that utilize these gel packs regarding appropriate use. 2. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product correction notice and share a copy of this notice. 3. POST a copy of this notification in your storeroom where the product is stored 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether or not you have affected product." Additional Information: "For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332."

    Distribution

    nationwide and Canada

    Quantity

    649213 units