Class I

Medical Device Recall: 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

Zyno Medical LLC · September 13, 2024

Reason for Recall

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

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

34,994 units (1819 units still need correction)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0005-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.