BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 5, 2023

    Recall

    Recall Number
    Z-1160-2023
    Event Number
    91562
    Firm
    S & MOHR AMERICA, S.A. DE C.V. Circuito De La Industria Poniente Lote 10 C Estado De Mexico Mexico
    FEI Number
    3020777588
    Product Code
    CAH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 5, 2023
    Posted
    February 22, 2023

    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"

    Action

    On or about 01/10/2023, the firm emailed a Customer Notification to customers notifying them that specific lots of Breathing Circuits were incorrectly label with the manufacturing dated as the expiration date for the product. The correct expiration dates range from 07/22/2027 to 07/26/2027 (5 year shelf-life). Customers are informed that the affected products can be used without risk to the patient up and until July 2027. For questions, contact Quality Assurance Department at +905426624107 Monday through Friday between 8:00 a.m. to 5:00 p.m. EST

    Distribution

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

    Quantity

    1,320 masks