Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parent...
FDA Recall #Z-1183-2024 — Class II — December 20, 2023
Product Description
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
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
Recalling Firm
Zyno Medical LLC — Natick, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
574 units
Distribution
Nationwide
Code Information
UDI: 00814371020037 software version 5.2.05
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated