Recall Z-0050-05 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc
Convenience Kits containing Inject8 or Inject10 syringes.
| Date | Oct 28, 2004 (initiated Sep 14, 2004) |
| Status | Terminated |
| Reason | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. |
| Root cause | Other |
| Action | All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees. |
| Quantity | 143 kits |
| Distribution | Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.