Z-1190-2008

Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for...

Name: Z-1190-2008 Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for...
Creator: Steris Corp
Published: 2008-02-19
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2008-02-19 / Terminated / root cause: design

FDA source

Steris Corp began a recall of Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes on 2008-02-19. The reason FDA records is "Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1190-2008
Status: Terminated
Initiated: 2008-02-19
Posted: 2008-08-05
Terminated: 2012-02-24
Recalling firm: STERIS Corporation
Product: Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
Product code: MED Sterilant, Medical Devices
Reason for recall: Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.
Root cause tag: design
FDA root cause: Device Design
Action: Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.
Quantity in commerce: 28,766 units
Distribution: Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.
Product codes and lots: All codes

Product code MED

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)