Recall Z-0490-2009 ยท FCG Biopsy Needle
Boston Scientific Corp
Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-107, REF M0065001070 and M0065001071. 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.
| Date | Jan 12, 2009 (initiated Oct 17, 2008) |
| Status | Terminated |
| Reason | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 14,254 of all 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, Tai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040893 | EASY CORE BIOPSY SYSTEM Boston Scientific Corp, May 6, 2004 |