BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

    Recall: Z-1120-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1120-2024
    Event ID
    93800
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    November 15, 2023
    Classification Date
    February 24, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

    Reason

    Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

    Code Info

    REF DYND06002, UDI/DI 40080196816645 (case), 10080196816644 (unit), Lot Numbers: 2022041290, 2022051090, 2022062090, 2022081190, 2022081790, 2022101990, 2022102090, 2022111490, 2023050390, 2023050890, 2023042890, 2023050490, 2023063090, 2023062990, 2023070390, 2023072890, 2023082590

    Distribution

    Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

    Quantity

    72,624 units