Recall Z-0048-05 ยท DXT Injector And Syringe, Angiographic
Merit Medical Systems, Inc
8 ml Inject8 Coronary Control Syringe, sterile.
| 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 | 11, 332 syringes |
| 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
| K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC Merit Medical Systems, Inc., Feb 11, 1988 |