Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
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.
US Nationwide and Internationally to countries of: Canada, Malaysia.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1909-2025