[pending] ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Pending LLM rewrite. Source: FDA_DEVICE Z-1910-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- Manufacturer
- Healthmark Industries Co., Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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