Recall Z-0506-2025 ยท FRN Pump, Infusion
Zyno Medical LLC
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
| Date | Nov 21, 2024 (initiated Oct 18, 2024) |
| Status | Open, Classified |
| Reason | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. |
| Root cause | Device Design |
| Action | Zyno Medical notified consignees on 10/18/2024 via email. Consignees were instructed that the updated notification supersedes current labeling and includes the following instructions: To maintain the health and runtime of the battery, it is recommended to plug the battery into AC Mains in for at least 6 hours every 30 days to fully charge the battery. Additionally, for scenarios where the Z800 pump is left plugged into AC Mains for extended periods of time, it is recommended to unplug for up to 5 seconds and re-plug the Z800 pump back into AC Mains at least every 30 days to activate the inte |
| Quantity | 34,994 units |
| Distribution | This product is distributed only in the United States. |
| FDA record | Open on fda.gov |