Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-114, REF M0065001140 and M0065001141. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
This recall has been terminated (originally issued January 12, 2009).
- Company
- Boston Scientific Corp
- Recall Initiated
- October 17, 2008
- Posted
- January 12, 2009
- Terminated
- December 15, 2009
- Recall Number
- Z-0492-2009
- Quantity
- 14,254 of all devices.
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
Distribution
Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
Lot / Code Info
Lots 0011520768, 0011539485, 0011579957, 0011583953, 0011628247, 0011633061 and 0011657171.
Root Cause
Nonconforming Material/Component
Action Taken
U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.