FDA recall Z-0005-2025

Product

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Reason for recall

There is a defect in the air-in-line software algorithm.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-09-13

Report date

2024-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0005-2025