Recall Z-2246-2009 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182480 18-248 RENEGADE 105/3.0/2.5/.021/20/STRAIGHT M001182510 18-251 F/G RENEGADE 150/10/1TIP M001182520 18-25
| 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 | 28,947 (11,050 US; 17,897 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 |
510(k) clearances named in this recall
| K020012 | MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific/Medi-Tech, Jan 29, 2002 |