Recall Z-0913-03 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc
Custom Kit
| Date | Jun 5, 2003 (initiated May 16, 2003) |
| Status | Terminated |
| Reason | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. |
| Root cause | Other |
| Action | On 5/16/2003, all distributors and consignees were notified by letter. |
| Quantity | 20 kits |
| Distribution | Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.