FDA-Device2014-07-16Class II
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Cenorin, LLC
Hazard
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
Sold states
Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
Affected count
25 HLD systems
Manufactured in
6324 S 199th Pl Ste 107, Kent, WA, United States
Products
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2014Don't want to check this manually?
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