BEUDAMED
    FDA Enforcement Class II Ongoing

    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

    Recall: Z-1365-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1365-2025
    Event ID
    96401
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 13, 2025
    Classification Date
    March 14, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

    Reason

    Potential breach in pouch packaging which could lead to loss of sterility.

    Code Info

    Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .

    Distribution

    US Nationwide distribution.

    Quantity

    114 units