Recall Z-2244-2009 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20 M001182840 18-284 11294909 RENEGADE HI FLO 105/10 M001182850 18-285 12703162 RENEGADE HI FLO 105/20 M001182860 18-286 11339895 R
| Date | Sep 24, 2009 (initiated Aug 26, 2009) |
| Status | Terminated |
| Reason | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. |
| Root cause | Packaging |
| Action | Consignees were sent a Boston Scientific Urgent Medical Device Recall Removal - Immediate Action Required letter Dated August 26,2009. The letter was addressed to Risk Manager / Field Action Contact. The letter described the problem and product involved. Advised consignees to segregate the affected product and return it to Boston Scientific. Requested the return and completion of The Account Reply Verification Tracking form enclosed. Replacements will be issued for all recalled product that is properly returned to Boston Scientific. |
| Quantity | 80,885 (51,491 US; 29,394 OUS) |
| Distribution | Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finlan |
| FDA record | Open on fda.gov |