Device product
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Z-1868-2025
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 96796
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 613 units
- Official record key
device-enforcement:Z-1868-2025
Official wording
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Code information: Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Unreleased software versions were installed on distributed devices without verification or validation.