Reported Oct 16, 2024 · Ongoing

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…

Zyno Medical LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zyno Medical LLC · 177 Pine St · Natick, MA · 01760-1331

- 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

Lot codes and dates: UDI-DIZ-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
Amount recalled: 34,994 units (1819 units still need correction)

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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8 in total.