BEUDAMED
    FDA Enforcement Class II Ongoing

    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

    Recall: Z-1910-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1910-2025
    Event ID
    96823
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Healthmark Industries Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    May 2, 2025
    Classification Date
    June 5, 2025
    Address
    18600 Malyn Blvd, N/A, Fraser, MI, 48026-3496, United States

    Description

    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

    Reason

    During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

    Code Info

    Lot Numbers: 200014 200015 200016 900153 900154 900155 900156 900157 900158 900159 900160 900161 900162 900163 900164 900165 900166 900167 900168 900169 900170 900171 900172 900173 900174 900175 900176 900177 103564 103312 103293 102807 102096 101673

    Distribution

    US Nationwide and Internationally to countries of: Canada, Malaysia.

    Quantity

    193035 units