BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

    Recall: Z-0171-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0171-2025
    Event ID
    95415
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 30, 2024
    Initiation Date
    September 4, 2024
    Classification Date
    October 23, 2024
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

    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.

    Code Info

    a) REF DYNJ44114, UDI/DI 40888277202055 (each), 10888277202054 (case), Lot Numbers: 24ABB398; b) REF DYNJ82663B, UDI/DI 40195327544325 (each), 10195327544324 (case), Lot Numbers: 23LBV498

    Distribution

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

    Quantity

    194 units