FDA-Device2025-06-11Class II
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Healthmark Industries Co., Inc.
Hazard
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.
Sold states
US Nationwide and Internationally to countries of: Canada, Malaysia.
Affected count
250000 units
Manufactured in
18600 Malyn Blvd, N/A, Fraser, MI, United States
Products
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1909-2025Don't want to check this manually?
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