BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

    Recall: Z-1115-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1115-2024
    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) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

    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 DYNDV2183A, UDI/DI 40195327050710 (case), 10195327050719 (unit), Lot Numbers: 22ABT635, 22ABY152, 22BBO850; b) REF DYNDH1641A, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; c) REF DYNDH1641AH, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; d) REF DYNDH1719A, UDI/DI40889942880486 (case), 10889942880485 (unit), Lot Numbers: 23ABC589, 23ABR972, 23BBS014

    Distribution

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