FDA-Device2024-11-27Class II
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.
Zyno Medical LLC
Hazard
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Sold states
This product is distributed only in the United States.
Affected count
34,994 units
Manufactured in
177 Pine St, N/A, Natick, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2025Don't want to check this manually?
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