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FDASeptember 13, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

zyno medicalzyno

UPCs

00814371020006008143710200200081437102001300814371020037

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear