Recall Z-0005-2025 ยท FRN Pump, Infusion
Zyno Medical LLC
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
| Date | Oct 9, 2024 (initiated Sep 13, 2024) |
| Status | Open, Classified |
| Reason | There is a defect in the air-in-line software algorithm. |
| Root cause | Process change control |
| Action | An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated 9/13/24 was sent to customers. Mitigation Zyno Medical LLC is mitigating this software issue by conducting a voluntary medical device correction to remove the faulty software and correctly install software that is free of this defect. Recommended Actions 1. Actions to Address the Issue During Use Note that only the devices listed in this letter are affected. No other products are involved in this action. Discontinue use of the affected device and proceed to the instructions for return of the device in Recommended Action b |
| Quantity | 34,994 units (1819 units still need correction) |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |