BEUDAMED
    FDA Enforcement Class II Ongoing

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    Recall: Z-1103-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1103-2025
    Event ID
    96067
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    New Medical Technologies Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    December 19, 2024
    Classification Date
    February 5, 2025
    Address
    Wankdorffeldstrasse 104, Bern, N/A, Switzerland

    Description

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    Reason

    During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

    Code Info

    Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA and the country of Canada.

    Quantity

    430 units (43 packs of 10)