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.
Recall
- Recall Number
- Z-0492-2009
- Event Number
- 50087
- Firm
- Boston Scientific Corp
- FEI Number
- 1828132
- Product Code
- FCG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 17, 2008
- Posted
- January 12, 2009
- Terminated
- December 15, 2009
- Address
- 780 Brookside Dr, Spencer, IN, 47460-1080
Description
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.
These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
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.
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.
14,254 of all devices.