Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, m
FDA device recall Z-1110-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Lack of assurance of sterility, as the sterile barrier may fail.
- Action taken
- Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
- Root cause
- Other
- Status
- Terminated
- Product code
- LQR
- Distribution
- Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Sau
- Date initiated
- 2006-05-19
- Date posted
- 2006-06-27
- Date terminated
- 2007-06-20
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPIC BILIARY CATHETER (K946358) | Boston Scientific Corp | 1995-04-11 |