Medical Device Recall: 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
Zyno Medical LLC · October 18, 2024
Reason for Recall
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Product Description
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.
Distribution
This product is distributed only in the United States.
States Affected
IN
Quantity Affected
34,994 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0506-2025
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.