Recall Z-1190-2008
Steris Corp · initiated February 19, 2008
Product
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
Codes / lots: All codes
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1190-2008
- Initiated
- February 19, 2008
- Posted by FDA
- August 5, 2008
- Terminated
- February 24, 2012
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 28,766 units
- Distribution
- Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.
- Recalling firm
- Steris Corp, Mentor, OH