Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
Zyno Medical is recalling certain Z-800 series infusion pumps due to a software issue, according to a medical device recall notice from the US Food and Drug Administration, which notes that this recall involves removing the devices from where they are used or sold.
Zyno Medical stated that 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 unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.
The worst case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, air in line that infuses a venous air embolism of up to 1mL, undetected flow reversal of drugs or parenteral fluids, and lowering of the Keep Vein Open (KVO) rate from 5 mL/hr to 1 mL/hr, which can lead to very low KVO flow rates and possibly cause a blood clot to form at the distal end of the catheter, ultimately leading to peripheral IV catheter (PIV) failure.
At this time, Zyno Medical has not reported any serious injuries or deaths. The FDA has identified this as a Class I recall, the most serious type.Â
What to Do
On May 7, 2025, Zyno Medical sent affected customers an email recommending the following actions:
- Discontinue use of affected devices and follow instructions for the return of the device.
- Check inventory for affected products, verify serial numbers, and confirm product location.
- Report any transferred product and pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location.
- A representative from Zyno Medical’s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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