BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No

    Recall: Z-1015-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-1015-2025
    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: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No

    Reason

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

    Code Info

    Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

    Distribution

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

    Quantity

    5,940 units