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Terminated

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/300-500/2mL/5vials M001761301 Contour SE/500-700/1mL/2vials M001761322 Contour SE/500-700/1mL/5vials M001761341 Contour SE/500-700/2mL/2vials M001761362 Contour SE/500-700/2mL/5vials M001761401 Contour SE/700-900/1mL/2vials M001761422 Contour SE/700-900/1mL/5vials M001761441 Contour SE/700-900/2mL/2vials M001761462 Contour SE/700-900/2mL/5vials M001761501 Contour SE/900-1200/1mL/2vials M001761522 Contour SE/900-1200/1mL/5vials M001761541 Contour SE/900-1200/2mL/2vials M001761562 Contour SE/900-1200/2mL/5vials

FDA Recall Z-2109-2009 · Posted 2009-09-15

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNAJ
Date Initiated2009-08-17
Date Terminated2011-12-18
Product Quantity45,724 (13,048 US, 45,724 OUS)

Reason for Recall

Compromised 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

Firm Action

Boston 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.

Root Cause

Process design

Distribution Pattern

Worldwide 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, Jordan, South Korea, Kuwait, Lebanon, Latvia, Libya, Mexico, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Poland, Puerto Rico, Portugal, Russian Fed., Saudi Arabia, Sweden, Slovakia, Tunisia, Turkey, Taiwan, Ukraine, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETERBoston Scientific Corp · 2003-09-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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