FDA recall Z-0523-2025

Zyno Medical LLC · Class III · device

Product

Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: 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 physician or other certified healthcare professional.

Reason for recall

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Distribution

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

Key facts

Status
Ongoing
Initiation date
2024-09-30
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2025