Recall Z-1995-2014— Cenorin, LLC
Class II · Terminated
Class II FDA medical device recall by Cenorin, LLC, initiated 2013-01-24, terminated 2015-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.. Reason: 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..
- Recalling firm
- Cenorin, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-24
- Terminated
- 2015-02-10
- Firm location
- Kent, WA, United States
Product description
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.