Steris Reliance 1227 Washer/Disinfector Recalled for Chemical Alarm Failure
Steris is recalling Reliance 1227 Washer/Disinfector units because the low chemical level alarm does not operate as intended, potentially preventing proper cleaning of patient care items.
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 3/5 (High).
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 involves a risk-of-harm product (medical device) where the failure could lead to improper cleaning and disinfection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Steris Corporation is recalling 118 units of the Reliance 1227 Cart and Utensil Washer/Disinfector (models FW03101, FW03102, and FW03S003). The recall is due to a defect in the Chemical Low Level alarm, which is designed to prevent users from starting a cycle when chemical levels are low. Currently, the alarm only triggers at the next power-up or when accessing service mode, rather than immediately when the low chemical condition occurs.
The failure to identify low or empty chemical levels could result in bedpans, urinals, basins, case carts, beds, theater shoes, and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse. The affected units were distributed nationwide in the United States and in Canada.
Healthcare facilities and users of these devices should stop using the affected units and contact Steris Corporation for further instructions on the recall.
The recalled product
- Product
- Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product 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, theatre shoes and…
- Manufacturer
- Steris Corporation
- Affected units
- 118
Distribution
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