Class III

Medical Device Recall: 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 p

Zyno Medical LLC · September 30, 2024

Reason for Recall

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.

Product Description

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.

Distribution

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

States Affected

AL, FL, LA, MI, NE, NJ, OH, TX

Quantity Affected

100 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0523-2025

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.