Zyno Medical LLC: 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

Hazard

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

Details from the source

Reason for recall: There is a defect in the air-in-line software algorithm. Distribution: US Nationwide. Quantity: 34,994 units (1819 units still need correction) Lot/code info: UDI-DI: Z-800 - 00814371020006 Z-800W - 00814371020020 Z-800F - 00814371020013 Z-800WF - 00814371020037 Lot Numbers: 190722360 20110921-SH 20111005-SH 20111102-SH 20111212-SH 20120105-SH 20120222-SH 20120501-SH 20120612-SH 20120719-SH 20120809-SH 20190809-SH 20120910-SH-1 20121213-sh 20130123-SH 20130227-SH 20120417-SH 20130511-SH 20130517-SH 20130609-SH 20130701-SH 20130812-SH 20131024-SH

UPC codes

00814371020006, 00814371020020, 00814371020013, 00814371020037

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.