FDA-Device2024-12-04Class III
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.
Zyno Medical LLC
Hazard
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.
Sold states
Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
Affected count
100 units
Manufactured in
177 Pine St, Natick, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2025Don't want to check this manually?
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