Recall Z-2036-2014 ยท MEC Disinfector, Medical Devices
Steris Corporation
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 reusable items used in the care of patients.
| Date | Jul 10, 2014 (initiated Jun 30, 2014) |
| Status | Terminated |
| Reason | STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable. |
| Root cause | Device Design |
| Action | Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion. |
| Quantity | 37 |
| Distribution | US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.