ClearanceBrief
Recall Z-2109-2009 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

Boston Scientific Corporation

Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE/100-300/1mL/2vials M001761122 Contour SE/100-300/1mL/5vials M001761141 Contour SE/100-300/2mL/2vials M001761162 Contour SE/100-300/2mL/5vials M001761201 Contour SE/300-500/1mL/2vials M001761222 Contour SE/300-500/1mL/5vials M001761241 Contour SE/300-500/2mL/2vials M001761262 Contour SE/

DateSep 15, 2009 (initiated Aug 17, 2009)
StatusTerminated
ReasonCompromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached. The breach of sterility could l
Root causeProcess design
ActionBoston Scientific sent consignees an "Urgent Medical Device Recall Removal" letter dated August 28, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and the product and advised the consignee to cease immediately the distribution and use of the product. Requested consignees to return affected product to Boston Scientific. The letter enclosed the Recall Instructions, Reply Verification Tracking Form and Field Action Return Shipping Label.
Quantity45,724 (13,048 US, 45,724 OUS)
DistributionWorldwide distribution: USA, United Arab Emir., Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jor
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
Boston Scientific Corp, Sep 23, 2003