Company: Zyno Medical LLC
Date of Enforcement Report: 10/9/2024
Class II
PRODUCT
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Recall Number:
Z-0005-2025
REASON:
There is a defect in the air-in-line software algorithm.
RECALLING FIRM/MANUFACTURER:
Zyno Medical LLC
VOLUME OF PRODUCT IN COMMERCE:
1819 units
DISTRIBUTION:
US Nationwide
