BEUDAMED
    FDA Enforcement Class II Terminated

    Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

    Recall: Z-0941-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0941-2022
    Event ID
    89821
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 9, 2022
    Classification Date
    April 14, 2022
    Termination Date
    May 26, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

    Reason

    The mask cuff may disconnect from the device's breathing tube.

    Code Info

    Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)

    Distribution

    US Nationwide distribution.

    Quantity

    8990 cases