Zyno Medical LLC recalls Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to p…

Recall date

October 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0506-2025

FDA classification

Class II

Brand / firm

Zyno Medical LLC

Sold / distributed

This product is distributed only in the United States.

Why it was recalled

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.