Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect
Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to heat water for pasteurization, which is a risk-of-harm product defect where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cenorin, LLC is recalling 25 units of the HLD System, Model 610, a medical device cleaning and high-level disinfection washer/pasteurizer. The recall was initiated because the temperature sensor/control system may provide a false temperature reading. This defect caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
The affected units were distributed worldwide, including in the United States (California, Delaware, Florida, Massachusetts, Michigan, New York, Pennsylvania, Texas, Utah, Washington, and Wisconsin) and in Uruguay and Taiwan. Specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities and users should stop using the affected HLD System Model 610 units immediately. They should contact Cenorin, LLC for instructions on how to resolve the issue, which may involve repair or replacement of the temperature sensor/control system.
The recalled product
- Product
- HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
- Manufacturer
- Cenorin, LLC
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 610601
- 610603
- 610703
- 610704
- 610705
- 610707
- 610708
- 610802
- 610803
- 610804
- 610901
- 610903
- 610904
- 610905
- 611001
- 611002
- 611004
- 611101
- 611102
- 611103
Distribution
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