Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400
- Recall Initiated
- December 20, 2006
- Posted
- March 13, 2007
- Terminated
- December 12, 2007
- Recall Number
- Z-0607-2007
- Quantity
- 8,511 for Recalls Z-0604-0609-2007
- Firm Location
- Scientific Place Natick, MA
Reason for Recall
Guidewire restriction during use (excessive adhesive in the guidewire lumen)
Distribution
Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
Lot / Code Info
Lot Numbers: 7928218, 7940824, 7959297, 7979465, 8016999, 8017000, 8041037, 8052775, 8093630, 8113554, 8113555, 8155386, 8155387, 8222854, 8247383, 8247384, 8247385, 8251326, 8251327, 8263403, 8263404, 8268291, 8364159, 8389892, 8423296, 8431392, 8442255, 8449736, 8490449, 8490450, 8502340, 8502341, 8502343, 8502344, 8502345, 8502346, 8503289, 8530084, 8530085, 8547344, 8603144, 8620590, 8624525, 8688101, 8688102, 8724565, 8727811, 8736211, 8797653, 8797654, 8829556, 8829557, 8831248, 8871693, 8871694, 8876235, 8876236, 8909940, 8909941, 8948216, 8948216, 8952271, 8952271, 8952432, 9131974, 9131975, 9131976, 9131977, 9131978, 9131979, 9131980
Root Cause
Other
Action Taken
On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.