If your email program has trouble displaying this email, view as a webpage.

Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue

The FDA is aware that that Zyno Medical has issued a letter to affected customers recommending certain models of Z-800 infusion pumps be removed from where they are used or sold. Certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience for unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.

At this time, Zyno Medical has not reported any serious injuries or deaths.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Zyno Medical at feedback@intuvie.com or 508-650-2008.