Health product recall

Reliance 1227 Cart and Utensil Washer/Disinfector (2018-05-21)

Starting date:
May 21, 2018
Posting date:
July 27, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67310

Affected products

Reliance 1227 Cart and Utensil Washer/Disinfector

Reason

STERIS has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector's "Chemical Low Level" alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical situation occurs, the alarm will only be generated at the unit's next power-up or when accessing service mode. Assuming pre-cleaning and post-processing visual inspection activities are completed in accordance with Good Hospital Practice, the Reliance 1227 Cart Washer's thermal disinfecting properties are not affected by the software issue identified.

Affected products

Reliance 1227 Cart and Utensil Washer/Disinfector

Lot or serial number

S/N: 3605113001
S/N: 3605415029
S/N: 3608215021
S/N: 3608718001
S/N: 3611417015
S/N: 3616714023
S/N: 3616814019
S/N: 3630814002
S/N: 3632116001
S/N: 3633015001

Model or catalog number

FW03-101
FW03-102

Companies
Manufacturer

Steris Canada Corporation

490 Boul. Armand-Paris

Quebec

G1C 8A3

Quebec

CANADA