Recall Z-1221-06 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Kensey Nash Corp
TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
| 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 | 15 boxes |
| 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 |