BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V

    Recall: Z-1123-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1123-2024
    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: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V

    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 CDS984900M, UDI/DI 40195327265671 (case), 10195327265670 (unit), Lot Numbers: 22KBW682; b) REF CDS983913S, UDI/DI 40195327057139 (case), 10195327057138 (unit), Lot Numbers: 22EBH289, 22EBI056, 22GBC582, 22GBH056, 22JBN751, 22NBC011; c) REF CDS983913T, UDI/DI 40195327238378 (case), 10195327238377 (unit), Lot Numbers: 22KBK694, 23BBA876, 23BBA877, 23BBN921; d) REF CDS983913U, UDI/DI 40195327403158 (case), 10195327403157 (unit), Lot Numbers: 23EBE521, 23EBK643; e) REF CDS983913V, UDI/DI 40195327417820 (case), 10195327417819 (unit), Lot Numbers: 23GBL963, 23GBO775, 23HBI553, 23IBR322

    Distribution

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

    Quantity

    533 units