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Zyno Medical LLC recalls Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p
Recalled June 18, 2025 · FDA recall Z-1868-2025 · Zyno Medical
Hazard
Unreleased software versions were installed on distributed devices without verification or validation. · FDA Class I
Units
613 units
Sold at
US Nationwide
Description
Unreleased software versions were installed on distributed devices without verification or validation.
Product
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Manufacturer(s)
Zyno Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →