Z-1910-2025 Class II Ongoing
FDA device recall Z-1910-2025 was initiated by Healthmark Industries Co., Inc. on May 2, 2025 and is designated Class II. 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. Healthmar… The recall status is ongoing. Affected quantity: 193035 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- May 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193035 units
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.
Distribution Pattern
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