BEUDAMED
    FDA Enforcement Class II Ongoing

    HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

    Recall: Z-1146-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1146-2024
    Event ID
    93818
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMD Medicom Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    December 21, 2023
    Classification Date
    February 16, 2024
    Address
    2555 Ch de L'Aviation, N/A, Montreal, N/A, N/A, Canada

    Description

    HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

    Reason

    Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

    Code Info

    Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;

    Distribution

    US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.

    Quantity

    720 cases (10 boxes/case and 50 masks/box)