BEUDAMED
    FDA Enforcement Class I Ongoing

    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

    Recall: Z-0562-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0562-2024
    Event ID
    93327
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2024
    Initiation Date
    October 16, 2023
    Classification Date
    December 22, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

    Reason

    The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

    Code Info

    (1) EDUC05038B - Lot numbers 22IDA181, 22FDB543, and 22ADB550, case UPC40195327019878;

    Distribution

    US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

    Quantity

    172 kits