Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
FDA Recall Z-1112-06 · Posted 2006-06-27
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeLQR
Date Initiated2006-05-19
Date Terminated2007-06-20
Reason for Recall
Lack of assurance of sterility, as the sterile barrier may fail.
Firm Action
Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.