Z-1960-2011

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant...

Name: Z-1960-2011 STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant...
Creator: Steris Corporation Hopkins Facility
Published: 2011-03-14
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2011-03-14 / Terminated / root cause: sterility

FDA source

Steris Corporation Hopkins Facility began a recall of STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical... on 2011-03-14. The reason FDA records is "The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1960-2011
Status: Terminated
Initiated: 2011-03-14
Posted: 2011-04-12
Terminated: 2013-03-13
Recalling firm: STERIS Corporation
Product: STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
Product code: MED Sterilant, Medical Devices
Reason for recall: The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco
Root cause tag: sterility
FDA root cause: Other
Action: The firm, STERIS, Issued an 'Urgent Field Correction Notice' dated March 14, 2011 addressed to their Hospital Administrator, or Manager, and Risk Manager customers on March 18, 2011. The notification letter describes the product subject to field correction and the problem that exists with the language omission present in the printout display and Operator Manual messages which warn of an incomplete or aborted processing cycle. The notification goes on to state that there is no health hazard involved in this error, as the users are still made aware that the processing cycle has not been successfully completed. The notification goes on to remind the user/customers that in case of any incomplete, cancelled or aborted cycle, the users are instructed to process devices in the cycle following the directions contained in the Operator Manual. Lastly, the notification letter informs the user/customers that the company will be installing new software on the recalled systems in order to revise the language on the cycle printout and the display screen warning of a disrupted cycle. It also states that a STERIS Service Representative will be contacting each facility in order to schedule installation of the new software. The notification also provides the customers with a 1-800 telephone number for STERIS Field Service Dispatch, to be used if the customers have questions or want to request additional information. It also provides a local telephone no. 1-440-392-7455, for obtaining additional information from the firm's Director, Div. of Low Temperature Sterilization at: 1-440-392-7455.
Quantity in commerce: 106 units
Distribution: Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.
Product codes and lots: All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.

Product code MED

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)