BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No

    Recall: Z-1012-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-1012-2025
    Event ID
    96068
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Trinity Sterile, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    December 13, 2024
    Classification Date
    January 22, 2025
    Address
    201 Kiley Dr, Salisbury, MD, 21801-2249, United States

    Description

    Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No

    Reason

    Potential for hole in package compromising sterility of the medical kit.

    Code Info

    Model No IM46062, UDI-DI 10853155008769, Lot Number 600022

    Distribution

    US Nationwide distribution in the states of MD, PA, TN and TX.

    Quantity

    1,980 units