Zyno Medical Infusion Pump Recall

Publish Date : 10/15/2024

Zyno Medical has issued a recall for its Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps due to a software defect in the air-in-line detection system. This defect could allow air bubbles larger than expected (1.0 mL) to pass into a patient’s bloodstream, potentially leading to serious health risks such as vascular air embolism, irregular heartbeat, heart attack, stroke, seizures, or even death.

The affected devices have specific software versions and UDIs. Zyno Medical sent an urgent correction letter on September 13, 2024, advising customers to stop using the affected pumps, return them for a software update, and complete a response verification form. Customers are also instructed to ensure this notice reaches all relevant parties, including those at other locations where the devices may have been transferred.

These infusion systems are used under medical supervision for administering essential fluids, blood, or nutrition intravenously.