BEUDAMED
    FDA Recall Open, Classified

    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

    Recall: Z-2450-2023 · Initiated August 8, 2023

    Recall

    Recall Number
    Z-2450-2023
    Event Number
    92799
    Firm
    Mallinckrodt Manufacturing LLC
    FEI Number
    3004531588
    Product Code
    BZO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 8, 2023
    Posted
    September 9, 2023
    Address
    6603 Femrite Dr, Madison, WI, 53718-6801

    Description

    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

    Reason

    The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

    Action

    Mallinckrodt Pharmaceuticals issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 08/08/2023 via FedEx. the notice explained the issue, risks associated with the failure, and requested the return of the device.

    Distribution

    Worldwide Distribution

    Quantity

    13,602 units