Recall Z-1113-06 ยท LQR Dislodger, Stone, Biliary
Boston Scientific Corp
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519.
| Date | Jun 27, 2006 (initiated May 19, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as the sterile barrier may fail. |
| Root cause | Other |
| Action | Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified. |
| Distribution | Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946358 | ENDOSCOPIC BILIARY CATHETER Boston Scientific Corp, Apr 11, 1995 |