FDA recall Z-1865-2025

Zyno Medical LLC · Class I · device

Product

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Reason for recall

Unreleased software versions were installed on distributed devices without verification or validation.

Distribution

US Nationwide

Key facts

Status
Ongoing
Initiation date
2025-05-07
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1865-2025