Getinge 46-Series Medical Washer-Disinfector Recalled for Sediment Residuals
Getinge Disinfection AB is recalling 46-Series Medical Washer-Disinfector models 46-4 and 46-5 due to sediment residuals in the manifold caused by air pockets.
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: The recall is classified as FDA Class II. The hazard involves sediment residuals due to air pockets, which is a functional defect without reported injuries or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Getinge Disinfection AB is recalling the Getinge 46-Series Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer. The recall involves 551 units distributed in the United States and Canada.
The firm initiated the recall after receiving complaints regarding sediment residuals in the manifold of the washer and disinfector. A detailed root cause analysis identified the problem as insufficient water flow throughout the manifold due to the formation of air pockets where sedimentation may occur.
These devices are Class II medical devices exempt from 510(k) requirements, used in healthcare facilities and laboratories for decontaminating reusable items such as instruments, utensils, anesthesia sets, and glassware. Healthcare facilities should contact Getinge Disinfection AB for instructions on how to address the issue.
The recalled product
- Product
- GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia…
- Manufacturer
- Getinge Disinfection Ab
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)
- Serial Numbers: SEV0810077
- SEV0537108
- SEV0633084
- W50030454
- SEV0724143
- SEV0724146
- SEV0609110
- W50044787
- SEV0533068
- W50042461
- W50023731
- W50023732
- W50038744
- W50028760
- SEV0802081
- W50015468
- W50042473
- W50045852
- W50048201
- W50041156
Distribution
Distributed nationwide across the United States.
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