BEUDAMED
    FDA Enforcement Class II Terminated

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

    Recall: Z-0495-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0495-2020
    Event ID
    84118
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AMD Medicom Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    October 11, 2019
    Classification Date
    November 19, 2019
    Termination Date
    September 14, 2021
    Address
    1200 55e Ave, N/A, Lachine, N/A, N/A, Canada

    Description

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

    Reason

    Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

    Code Info

    Lot 1917

    Distribution

    The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.

    Quantity

    112 cases (500 units/case)