Recall Z-0489-2009
Boston Scientific Corp · initiated October 17, 2008
Product
Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061. 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.
Codes / lots: Lot 0011524376.
Reason for recall
These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
FDA-determined 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.
Details
- Recall number
- Z-0489-2009
- Initiated
- October 17, 2008
- Posted by FDA
- January 12, 2009
- Terminated
- December 15, 2009
- Product code
- FCG – Biopsy Needle
- 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, Taiwan, Turkey, Japan and United Arab Emirates.
- Recalling firm
- Boston Scientific Corp, Spencer, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0487-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0488-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0490-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0491-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0492-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0493-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0494-2009 | Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |
| Z-0495-2009 | Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 10/17/2008Terminated |