Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
Recall
- Recall Number
- Z-1010-2009
- Event Number
- 50861
- Firm
- Boston Scientific Corp
- FEI Number
- 1828132
- Product Code
- LQR
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- January 8, 2009
- Posted
- March 11, 2009
- Terminated
- October 22, 2009
- Address
- 780 Brookside Dr, Spencer, IN, 47460-1080
Description
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
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.
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.
Nationwide.
294 of all products.