Recall Z-0547-03 ยท MLR Sterilizer, Chemical
Steris Corp
C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
| Date | Feb 6, 2003 (initiated Mar 7, 2003) |
| Status | Terminated |
| Reason | The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle. |
| Root cause | Other |
| Action | On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced. |
| Quantity | 1,140 units |
| Distribution | Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875280 | STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT Steris C/O Medical Device Consultants, Inc., Sep 13, 1988 |