Cenorin HLD Systems Model 610 Washer Recalled for Cleaning Fluid Defect
Cenorin LLC is voluntarily recalling 25 HLD Systems Model 610 Washer/High Level Disinfector units because they may not inject the proper amount of cleaning fluid, potentially failing to reduce debris.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a functional defect (inadequate cleaning) where no illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Cenorin LLC is voluntarily recalling 25 units of the HLD Systems Model 610 Washer/High Level Disinfector. The recall is due to a potential risk that the system may not inject the proper amount of cleaning fluid during the wash cycle. This defect may result in the system not achieving the desired level of debris reduction on reusable medical devices.
The affected units were distributed nationwide in the United States. The product is used to wash and disinfect reusable medical devices using high-temperature hot water and cleaning solutions. The recall notice does not specify specific dates of distribution or the exact number of units sold to end-users, only the total quantity of 25 systems involved in the recall.
Consumers and healthcare facilities should stop using the affected devices and contact Cenorin LLC for further instructions on how to proceed with the recall. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6…
- Manufacturer
- Cenorin, LLC
- Hazard
- 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
- 610902
- 611001
- 611002
- 611004
- 611102
- 611103
Distribution
Distributed nationwide across the United States.
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