FDA recall Z-1183-2024

Zyno Medical LLC · Class II · device

Product

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

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2023-12-20
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2024