FDADecember 20, 2023device
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 recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Ongoing
Brands named
zyno medicalzyno
UPCs
00814371020037
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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