FDA recall Z-1910-2025

Healthmark Industries Co., Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-05-02
Report date
2025-06-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fraser, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1910-2025