BEUDAMED
    FDA Recall Open, Classified

    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189

    Recall: Z-0970-2023 · Initiated December 14, 2022

    Recall

    Recall Number
    Z-0970-2023
    Event Number
    91322
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    GBX
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 14, 2022
    Posted
    January 18, 2023
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189

    Reason

    Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

    Action

    Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown above. 2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether you have affected product. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: . Hospital 800-964-5227 . Federal Government 800-444-1166 . Distributor 800-635-6021 . All other customers 888-444-5440 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

    Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

    Quantity

    921 units