Recall Z-1011-2009 ยท LQR Dislodger, Stone, Biliary
Boston Scientific Corp
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 facilita
| Date | Mar 11, 2009 (initiated Jan 8, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 294 of all products. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946358 | ENDOSCOPIC BILIARY CATHETER Boston Scientific Corp, Apr 11, 1995 |