BEUDAMED
    FDA Recall Open, Classified

    Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707

    Recall: Z-0175-2025 · Initiated September 4, 2024

    Recall

    Recall Number
    Z-0175-2025
    Event Number
    95415
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OHD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 4, 2024
    Posted
    October 23, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707

    Reason

    It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

    Action

    Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Panama.

    Quantity

    197 units