Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.
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-1109-06
- 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 588218, 7173503, 7907512, 8541152, 6553517, 7209058, 7923845, 8541153, 6573307, 7213538, 7938899, 6593724, 7238048, 7959199, 6628839, 7244918, 7978741, 6650500, 7312261, 7988003, 6663230, 7323058, 8012669, 6684869, 7345074, 8037031, 6684870, 7368731, 8056507, 6710850, 7394062, 8076206, 6731508, 7416357, 8076207, 6745329, 7441769, 8093643, 6762317, 7469187, 8115498, 6783937, 7487245, 8131913, 6798010, 7510076, 8146780, 6811675, 7536508, 8154851, 6832811, 7550048, 8165619, 6834085, 7570081, 8194623, 6843046, 7592340, 8221047, 6870688, 7613897, 8250992, 6893879, 7635034, 8262323, 6896571, 7635532, 8272381, 6917737, 7656406, 8301236, 6919072, 7701169, 8303922, 6939764, 7722952, 8304044, 6946002, 7738501, 8304054, 6965093, 7738922, 8326168, 6979350, 7773671, 8331426, 6988355, 7794744, 8337750, 7005425, 7813723, 8359941, 7037237, 7833511, 8378721, 7049995, 7833512, 8393169, 7052629, 7845564, 8414769, 7076211, 7845565, 8428051, 7096493, 7864321, 8444985, 7121618, 7891878, 8461221, 7143069, 7892977, 8489777, 7163174, 7900869 and 8509967.
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.