The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing,

FDA device recall Z-2122-2012 · posted 2012-08-01 · Terminated

Recall details

Recalling firm

Steris Corporation

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.

Action taken

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

Status

Terminated

Product code

MEC

Quantity affected

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,

Date initiated

2012-07-14

Date posted

2012-08-01

Date terminated

2014-06-06

Location

Mentor, OH