Recall Z-0158-04 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc
UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
| Date | Nov 27, 2003 (initiated Nov 5, 2003) |
| Status | Terminated |
| Reason | Angiographic catheter tips may separate during use. |
| Root cause | Other |
| Action | All 7 consignees were contacted by their sales representatives on 11/5-7/2003. |
| Quantity | 410 units |
| Distribution | FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical, Nov 15, 1994 |