BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024

    Recall: Z-1121-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1121-2024
    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) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024

    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 EDUC05053B, UDI/DI 40195327152759 (case), 10195327152758 (unit), Lot Numbers: 22HDA208; b) REF EDUC05054B, UDI/DI 40195327152766 (case), 10195327152765 (unit), Lot Numbers: 22FDA648, 22GDA631; c) REF EDUC05050B, UDI/DI 40195327166749 (case), 10195327166748 (unit), Lot Numbers: 22HLA620, 22HLB059, 22ILA209, 22ILA210, 22KLA131, 22LLA961, 23GLA207, 23GLA933, 23GLB218, 23HLB203; d) REF EDUC1024, UDI/DI 40195327493166 (case), 10195327493165 (unit), Lot Numbers: 23CDB444, 23EDB632, 23GDA553, 23GDB595, 23HDA559, 23IDA904, 23JDA398

    Distribution

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

    Quantity

    844 units