FDA recalls Zyno infusion pumps, citing risk of death
The U.S. Food and Drug Administration (FDA) has issued a serious recall on behalf of Zyno Medical for a line of infusion pumps due to a software error that has not undergone proper verification testing. The pumps, released with this incorrect version of their operational software, could experience significant performance problems, including errors in features that monitor potential air in lines, regulate alarms and prevent the reverse flow of fluids.
Zyno and the FDA warn that using the infusion systems at a keep vein open (KVO) rate from 1 mL/hr to 5 mL/hr can lead to very low flow rates and possibly cause a blood clot to form at the distal end of the catheter.
There have been no reported injuries. However, because these potential malfunctions could result in the over-delivery of drugs, potential embolism in a patient if air is in a line, and subsequent death, the recall has been designated the most serious of its type, a Class I.
What is being recalled?
The specific product line subject to the recall is the Zyno Medical Z-800 Infusion System. Numerous devices with varying serial numbers are all impacted, representing hundreds of pumps currently in supply houses and patient care settings nationwide.
The models impacted are Z-800, Z-800F, Z-800W and Z-800WF. For Unique Device Identifier (UDI) numbers and more specific product codes, please review the recall notice here.
Next steps
Zyno Medical sent all known customers an email on May 7 with instructions on what to do next. The FDA is providing the same instructions to spread awareness. If anyone is in possession of a pump impacted by this recall, use must be discontinued immediately and they are to be returned for a replacement or refund. The first step is to check to see if serial numbers match any from the notice, which is linked again here.
Instructions were sent with the email on how to initiate a return. However, customers can also contact Zyno at [email protected] or 508-650-2008.
Both the company and the FDA are asking that information about the recall be shared to ensure all infusion systems with the unapproved software are removed from the supply chain as soon as possible.
In the meantime, providers are asked to seek alternatives to meet the demands of patient care.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.