BEUDAMED
    FDA Enforcement Class I Ongoing

    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 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2450-2023
    Event ID
    92799
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mallinckrodt Manufacturing LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    August 8, 2023
    Classification Date
    September 8, 2023
    Address
    6603 Femrite Dr, Madison, WI, 53718-6801, United States

    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.

    Code Info

    a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237

    Distribution

    Worldwide Distribution

    Quantity

    13,602 units