Recall Z-1219-06 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Kensey Nash Corp
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.
| Date | Jul 12, 2006 (initiated May 24, 2006) |
| Status | Terminated |
| Reason | Volume control knob not able to go up to larger diameters |
| Root cause | Other |
| Action | A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position. |
| Quantity | 10 kits |
| Distribution | Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042040 | TRIACTIV SYSTEM Kensey Nash Corp., Mar 23, 2005 |