ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
FDA Recall #Z-1910-2025 — Class II — May 2, 2025
Product Description
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Reason for Recall
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.
Recalling Firm
Healthmark Industries Co., Inc. — Fraser, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
193035 units
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated