Recall Z-0078-06 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc
Merit Custom Procedure Kit
| Date | Oct 21, 2005 (initiated Sep 2, 2005) |
| Status | Terminated |
| Reason | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. |
| Root cause | Other |
| Action | Consignees were notified by letter on 9/2/2005. |
| Quantity | 84 units |
| Distribution | DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913682 | MERIT CUSTOM KIT Merit Medical Systems, Inc., Nov 15, 1991 |