BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0941-2022 · Initiated March 9, 2022

    Recall

    Recall Number
    Z-0941-2022
    Event Number
    89821
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    CAE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 9, 2022
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline Industries, Inc. notified all affected consignees via first class mail on March 8, 2022. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to be stored.

    Distribution

    US Nationwide distribution.

    Quantity

    8990 cases