The Zyno Medical Infusion Pump recall involves the following models and Unique Device Identifier (UDI) numbers, which were distributed to healthcare facilities nationwide:
- Z-800 (00814371020006)
- Z-800W (00814371020020)
- Z-800F (00814371020013)
- Z-800WF (00814371020037)
Zyno Medical LLC first alerted healthcare providers about the software defect in the air-in-line system of certain infusion pumps through an Urgent Medical Device Correction letter on September 13, 2024.
The letter instructed customers to immediately stop using the pumps, and provided directions for returning the devices for a necessary software update. The manufacturer further requested that healthcare professionals notify other users, including those at any locations where the devices may have been relocated.
The letter also asked customers to complete the Zyno Medical Infusion Pump—Air-In-Line Software Issue—Response Verification Form, which includes checking inventory for affected products, verifying serial numbers, confirming product locations, reporting transferred products, and signing and dating the completed form.
A representative from Zyno Medical’s partner company, Intuvie LLC, will contact customers to coordinate instructions for exchanging devices. U.S. customers with questions about the recall can contact their Zyno Medical local business partner or email feedback@intuvie.com.
In addition, customers can report adverse reactions or quality problems to the FDA Safety Information and Adverse Event Reporting Program, MedWatch.