Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston S
FDA device recall Z-1012-2009 · posted 2009-03-11 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- Action taken
- Consignees were notified via letter dated January 8, 2009 to discontinue use of the affected product and to return it to Boston Scientific. Customers were instructed to complete and fax the Reply Verification Tracking Form to Boston Scientific at 508-683-5578. Direct questions about this recall to your local Sales Representative.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LQR
- Quantity affected
- 294 of all products.
- Distribution
- Nationwide.
- Date initiated
- 2009-01-08
- Date posted
- 2009-03-11
- Date terminated
- 2009-10-22
- Location
- Spencer, IN
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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 |