FDA-Device2025-06-18Class I
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Zyno Medical LLC
Hazard
Unreleased software versions were installed on distributed devices without verification or validation.
Sold states
US Nationwide
Affected count
613 units
Manufactured in
177 Pine St, Natick, MA, United States
Products
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2025Don't want to check this manually?
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