Recall Z-0002-2017 ยท MAV Syringe, Balloon Inflation
Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
| Date | Aug 25, 2016 |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information. |
| Root cause | Labeling design |
| Action | Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690. |
| Quantity | 1,297 total units |
| Distribution | One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE Merit Medical Ireland, Ltd., Dec 19, 2012 |