C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Univers
FDA device recall Z-0547-03 · posted 2003-02-06 · Terminated
Recall details
- Recalling firm
- Steris Corp
- Reason for recall
- The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.
- Action taken
- On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 1,140 units
- Distribution
- Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
- Date initiated
- 2003-03-07
- Date posted
- 2003-02-06
- Date terminated
- 2004-02-05
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT (K875280) | Steris C/O Medical Device Consultants, Inc. | 1988-09-13 |