Company: Zyno Medical LLC
Date of Enforcement Report: 11/22/2024
Class: III
PRODUCT
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.
Recall Number:
Z-0523-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Zyno Medical LLC.
VOLUME OF PRODUCT IN COMMERCE:
100 units
DISTRIBUTION:
Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
