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Recall Observatory FDA recall evidence

Device product

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

Z-1910-2025

May 02, 2025

Class II

Product summary

Firm
Healthmark Industries Co., Inc.
Event
Event 96823
Status
Ongoing
Classification
Class II
Quantity
193035 units
Official record key
device-enforcement:Z-1910-2025

Official wording

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 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.