BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Pill Splitters; 1 each/box; 144 boxes/carton

    Recall: Z-1287-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1287-2022
    Event ID
    90196
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    May 11, 2022
    Classification Date
    June 24, 2022
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Pill Splitters; 1 each/box; 144 boxes/carton

    Reason

    Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.

    Code Info

    Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.

    Quantity

    840,087 each