Steris Recalls Reliance 1227 Washer Due to Door Handle Pin Deformation
Steris is recalling 37 Reliance 1227 Cart and Utensil Washer/Disinfector units because the door handle pin may deform or break, potentially rendering the door inoperable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is mechanical (door inoperability) with no reported injuries or illnesses.
Plain-English summary
Steris Corporation is recalling 37 units of the Reliance 1227 Cart and Utensil Washer/Disinfector. The device is intended for the cleaning and low-level disinfection of bedpans, urinals, basins, carts, beds, and other reusable items used in patient care.
The recall was initiated because the washer's door handle pin may deform when the door handle is rotated with sufficient force. If the pin deforms or breaks, the washer door may become inoperable. The affected units have serial numbers ranging from 3632511020 to 3613214010.
These units were distributed nationwide in the United States (AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA) and in Canada. The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for these units.
The recalled product
- Product
- Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous…
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 37
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 (1)
- Serial Number Range: 3632511020 - 3613214010
Distribution
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