BEUDAMED
    FDA Enforcement Class I Ongoing

    MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

    Recall: Z-1105-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1105-2024
    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: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

    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

    UDI/DI 40193489884501 (case), 10193489884500 (unit), Lot Numbers: 21LBT672, 22BBG831

    Distribution

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

    Quantity

    35 units