Recall Z-1960-2011
Steris Corporation Hopkins Facility · initiated March 14, 2011
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.
Codes / lots: All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.
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
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1960-2011
- Initiated
- March 14, 2011
- Posted by FDA
- April 12, 2011
- Terminated
- March 13, 2013
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 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.
- Recalling firm
- Steris Corporation Hopkins Facility, Mentor, OH