Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE/100-300/1
FDA device recall Z-2109-2009 · posted 2009-09-15 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- NAJ
- Quantity affected
- 45,724 (13,048 US, 45,724 OUS)
- Distribution
- Worldwide distribution: USA, United Arab Emir., Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Eg
- Date initiated
- 2009-08-17
- Date posted
- 2009-09-15
- Date terminated
- 2011-12-18
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (K030966) | Boston Scientific Corp | 2003-09-23 |