FDA recall Z-0506-2025

Zyno Medical LLC · Class II · device

Product

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

Reason for recall

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Distribution

This product is distributed only in the United States.

Key facts

Status
Ongoing
Initiation date
2024-10-18
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2025