Z-2122-2012Class II

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

Name: Z-2122-2012 The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in...
Creator: Steris Corporation
Published: 2012-07-14
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2012-07-14 / Terminated / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of 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... on 2012-07-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2122-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-14
Posted: 2012-08-01
Terminated: 2014-06-06
Recalling firm: STERIS Corporation
Product: 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.
Product code: MEC Disinfector, Medical Devices
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.
Root cause tag: labeling and UDI
FDA 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 regarding the STERIS visit to their facility, they can contact STERIS Field Service Dispatch at 1800-333-8828
Quantity in commerce: 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, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, UAE, United Kingdom and Canada.
Product codes and lots: The codes for the product are Julian date-coded. They follow the following pattern: AABBBCCDDD AA is a two digit code representing the manufacturing facility number BBB is a three digit code representing the day of the year that the device was manufactured CC is a two digit code representing the Julian year that the device was manufactured DDD is a three digit code representing the number of the number of the device manufactured that day. For example, a serial number of 3606499005 indicates that the device was manufactured in facility number 36, on the 64th day of the year of 1999, and the device was the 5th device manufactured that day. The serial number ranges for the devices being recalled are: RELIANCE¿ 130: 3606499005 3626709006 RELIANCE¿ 130L: 3629299006 3628809011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2122-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2122-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)