Recall Z-1190-2008 ยท MED Sterilant, Medical Devices
Steris Corp
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
| Date | Aug 5, 2008 (initiated Feb 19, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 28,766 units |
| Distribution | Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.