BEUDAMED
    FDA Recall Open, Classified

    DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

    Recall: Z-2227-2023 · Initiated March 28, 2023

    Recall

    Recall Number
    Z-2227-2023
    Event Number
    92572
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    CAE
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    March 28, 2023
    Posted
    July 21, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

    Reason

    The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.

    Action

    The consignee recall notification was sent out via first class mail and email on 03/28/2023. The letter instructs the consignee to over-label the Flexible Laryngeal Mask Airway Packs stating to Check the Expiration date of Lubricating Jelly MDS032280 and do not use if Expired . No product is to be returned back to Medline Industries, LP.

    Distribution

    Worldwide distribution - US Nationwide and the country of Bermuda.

    Quantity

    9945 ea