BEUDAMED
    FDA Enforcement Class III Ongoing

    abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

    Recall: Z-1160-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1160-2023
    Event ID
    91562
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    S & MOHR AMERICA, S.A. DE C.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2023
    Initiation Date
    January 5, 2023
    Classification Date
    February 22, 2023
    Address
    Circuito De La Industria Poniente Lote 10 C, N/A, Estado De Mexico, N/A, N/A, Mexico

    Description

    abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

    Reason

    Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

    Code Info

    Product Code: BC21087 Lot Number: SM6002.2207.12 Product Code: BC21088 Lot Number: SM6003.2507.12 Product Code: BC21273 Lot Number: SM6001.2207.12 Product Code: BC21089 Lot Number: SM6004.2607.12

    Distribution

    U.S. Nationwide distribution in the state of MN.

    Quantity

    1,320 masks