Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.
This recall has been terminated (originally issued June 27, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- May 19, 2006
- Posted
- June 27, 2006
- Terminated
- June 20, 2007
- Recall Number
- Z-1114-06
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility, as the sterile barrier may fail.
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.
Lot / Code Info
All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448, 7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756, 7938900, 8002453, 8271737 and 8502059.
Root Cause
Other
Action Taken
Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.