BEUDAMED
    FDA Recall Open, Classified

    Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

    Recall: Z-1443-2025 · Initiated February 11, 2025

    Recall

    Recall Number
    Z-1443-2025
    Event Number
    96374
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    PPB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 11, 2025
    Posted
    March 25, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

    Action

    Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    96 units