Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513. 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.
This recall has been terminated (originally issued March 11, 2009).
- Company
- Boston Scientific Corp
- Recall Initiated
- January 8, 2009
- Posted
- March 11, 2009
- Terminated
- October 22, 2009
- Recall Number
- Z-1011-2009
- Quantity
- 294 of all products.
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
Lot Numbers: 12001574 and 12002381.
Root Cause
Packaging
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.
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