Home / Recalls / Medical Devices
Zyno Medical LLC recalls 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
Recalled October 16, 2024 · FDA recall Z-0005-2025 · Zyno Medical
Hazard
There is a defect in the air-in-line software algorithm. · FDA Class I
Units
34,994 units (1819 units still need correction)
Sold at
US Nationwide.
Description
There is a defect in the air-in-line software algorithm.
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
Manufacturer(s)
Zyno Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →