BEUDAMED
    FDA Enforcement Class I Ongoing

    Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

    Recall: Z-1137-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1137-2024
    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: BREAST BIOPSY KIT, REF MNS4360

    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 MNS4360, UDI/DI 10653160141716 (case), 00653160141719 (unit), Lot Numbers: 2022091690, 2022112290, 2022120990

    Distribution

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

    Quantity

    120 units