BEUDAMED
    FDA Recall Open, Classified

    Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

    Recall: Z-1157-2024 · Initiated January 4, 2024

    Recall

    Recall Number
    Z-1157-2024
    Event Number
    93795
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    KYZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 4, 2024
    Posted
    September 30, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

    Reason

    Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).

    Action

    Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704

    Distribution

    US, Nationwide

    Quantity

    4831 units