Recall Z-1012-2009
Boston Scientific Corp · initiated January 8, 2009
Product
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515. 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.
Codes / lots: Lot Numbers: 11988198 and 11989069.
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.
FDA-determined 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.
Details
- Recall number
- Z-1012-2009
- Initiated
- January 8, 2009
- Posted by FDA
- March 11, 2009
- Terminated
- October 22, 2009
- Product code
- LQR – Dislodger, Stone, Biliary
- Quantity
- 294 of all products.
- Distribution
- Nationwide.
- Recalling firm
- Boston Scientific Corp, Spencer, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1010-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr…The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the… | 01/08/2009Terminated |
| Z-1011-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr…The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the… | 01/08/2009Terminated |