Recall Z-0829-03 ยท MLR Sterilizer, Chemical
Steris Corp
C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
| Date | May 15, 2003 (initiated Apr 23, 2003) |
| Status | Terminated |
| Reason | The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process. |
| Root cause | Other |
| Action | The firm notified their customers by telephone and letter on 4/23/2003. |
| Quantity | 138 units |
| Distribution | The product was shipped to end-users located nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.