Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
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-1110-06
- 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 558552, 7739212, 602212, 7753189, 6593723, 7794743, 6632145, 7814338, 6666397, 7836676, 6685227, 7864847, 6713444, 7885211, 6732190, 7938898, 6746552, 7959197, 6787368, 7979136, 6795091, 7997847, 6834079, 8001283, 6846985, 8079834, 6874028, 8119586, 6897533, 8133511, 6900226, 8170294, 6948065, 8203324, 6966289, 8250997, 6987748, 8306742, 6988354, 8306923, 7037239, 8409135, 7052984, 8430041, 7078441, 8459615, 7189065, 8533268, 7213471, 7244925, 7323059, 7351026, 7403584, 7442556, 7485763, 7536756, 7557104, 7656402, 7675613, 7701170 and 7722953.
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.