BEUDAMED
    FDA Recall Open, Classified

    Medline Leg bag, REF DYND12578

    Recall: Z-0534-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0534-2024
    Event Number
    93306
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FAQ
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    October 19, 2023
    Posted
    September 30, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Leg bag, REF DYND12578

    Reason

    Undeclared latex

    Action

    Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.

    Distribution

    US and Panama

    Quantity

    19406 devices