FDA-Device2024-03-06Class II
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Zyno Medical LLC
Hazard
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Sold states
Nationwide
Affected count
574 units
Manufactured in
177 Pine St, Natick, MA, United States
Products
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2024Don't want to check this manually?
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