Zyno Medical LLC recalls Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is int…

Recall date

September 30, 2024

Source

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

Recall number

Z-0523-2025

FDA classification

Class III

Brand / firm

Zyno Medical LLC

Sold / distributed

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

Why it was recalled

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: 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 physician or other certified healthcare professional.