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Zyno Medical LLC FDA Recalls
9 recalls on file across devices, 5 of them Class I and 9 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pClass IMay 7, 2025Unreleased software versions were installed on distributed d |
| Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a paClass IMay 7, 2025Unreleased software versions were installed on distributed d |
| Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a paClass IMay 7, 2025Unreleased software versions were installed on distributed d |
| Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patClass IMay 7, 2025Unreleased software versions were installed on distributed d |
| Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended Class IIOct 18, 2024Potential for the battery to deplete over time from self-dis |
| Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is iClass IIISep 30, 2024For the Z-800WF pumps, the WiFi software was not compatible |
| 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-800FClass ISep 13, 2024There is a defect in the air-in-line software algorithm. |
| Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion PumpsClass IIJun 4, 2024Zyno Medical has found that certain Z800, Z800F, Z800W, and |
| Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and Class IIDec 20, 2023When utlizing the patient query feature on the Zyno Medical |