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.
FDA Recall Z-2122-2012 · Posted 2012-08-01
Advertisement
Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMEC
Date Initiated2012-07-14
Date Terminated2014-06-06
Product Quantity367
Reason for Recall
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.
Firm 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 regarding the STERIS visit to their facility, they can contact STERIS Field Service Dispatch at 1800-333-8828
Root Cause
Labeling design
Distribution Pattern
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, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, UAE, United Kingdom and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement