Zyno Medical LLC: 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

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

Details from the source

Reason for recall: 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 Distribution: Nationwide Quantity: 574 units Lot/code info: UDI: 00814371020037 software version 5.2.05

UPC codes

00814371020037

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.