Recall Z-2122-2012 ยท MEC Disinfector, Medical Devices
Steris Corporation
The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.
| Date | Aug 1, 2012 (initiated Jul 14, 2012) |
| Status | Terminated |
| Reason | To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer. |
| Root cause | Labeling design |
| Action | Steris Corp. sent a Urgent Field Correction Notice dated July 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To ensure users are properly operating the Reliance 130 and 130L Cart Washers a 'door close' confirmation button and a door open delay will be installed on the affected cart washer(s). A STERIS Service Representative will contact the affected facilities to arrange for STERIS to upgrade their Reliance 130 and 130L Cart Washer(s). For further information or if affected customers have any questions reg |
| Quantity | 367 |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. and the countries of : Australia, South Korea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.