FDA-Device2013-04-10Class II

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

Zyno Medical LLC
Hazard

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Sold states
Nationwide Distribution.
Affected count
2589 units
Manufactured in
10 Tech Circle, N/A, Natick, MA, United States
Products
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2013

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