Zyno Medical LLC recalls 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…

Recall date

September 13, 2024

Source

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

Recall number

Z-0005-2025

FDA classification

Class I

Brand / firm

Zyno Medical LLC

Sold / distributed

US Nationwide.

Why it was recalled

There is a defect in the air-in-line software algorithm.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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