BEUDAMED
    FDA Recall Open, Classified

    see RES for description

    Recall: Z-2624-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-2624-2024
    Event Number
    94582
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OFT
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 8, 2024
    Posted
    August 27, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    see RES for description

    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 04/08/2024 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 these 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. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

    Distribution

    Worldwide distribution.

    Quantity

    1,679,067 units in total