Recall Z-1800-2008 ยท FPA Set, Administration, Intravascular
Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
| Date | Sep 11, 2008 (initiated Apr 8, 2008) |
| Status | Terminated |
| Reason | Convenience kits may contain non-filtered drip chambers. |
| Root cause | Mixed-up of materials/components |
| Action | An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter. |
| Quantity | 99 kits |
| Distribution | Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915678 | MERIT ADMINISTRATION SET Merit Medical Systems, Inc., Jul 30, 1992 |