Recall Z-2263-2024 ยท FRN Pump, Infusion
Zyno Medical LLC
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
| Date | Jul 3, 2024 (initiated Jun 4, 2024) |
| Status | Open, Classified |
| Reason | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power. |
| Root cause | Process control |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/4/24 was sent to customers. Recommended Actions When using a system that has been identified as having the power supply module issue, keep them plugged into an external AC mains power source. 1. Actions to Address the Issue During Use Operate the unit on AC mains power source. If the affected system is disconnected from the external AC mains power source and the system presents an audible low battery alarm, re-connect the system to the external AC mains power source. If the affected system is disconnected from the external |
| Quantity | 88 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130690 | Z-800 INFUSION SYSTEM Zyno Medical, LLC, Jun 12, 2013 |