Recall Z-1701-2008 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
| Date | Sep 4, 2008 (initiated Apr 15, 2008) |
| Status | Terminated |
| Reason | Convenience kits may be non-sterile due to inadequate package sealing. |
| Root cause | Process control |
| Action | Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497. |
| Quantity | 119 kits |
| Distribution | MO. Foreign distribution to Japan. No military or government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.