BEUDAMED
    FDA Enforcement Class I Ongoing

    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

    Recall: Z-1130-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1130-2024
    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

    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

    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

    a) REF MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850

    Distribution

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

    Quantity

    10391 units