Zyno Medical LLC

FDA Regulatory Profile

Summary

Total Recalls
16 (5 Class I)
510(k) Clearances
7
Inspections
7
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1868-2025Class IZ-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bMay 7, 2025
Z-1865-2025Class IZ-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bloMay 7, 2025
Z-1867-2025Class IZ-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blMay 7, 2025
Z-1866-2025Class IZ-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blMay 7, 2025
Z-0506-2025Class IIZ-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 InfusionOctober 18, 2024
Z-0523-2025Class IIIBrand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 September 30, 2024
Z-0005-2025Class IZ-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01September 13, 2024
Z-2263-2024Class IIZyno Medical Z800, Z800F, Z800W, and Z800WF Infusion PumpsJune 4, 2024
Z-1183-2024Class IIZyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteraDecember 20, 2023
Z-2058-2019Class IIZyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical May 29, 2019
Z-2059-2019Class IIZyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno MedicalMay 29, 2019
Z-2894-2016Class IIZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity FeJuly 29, 2016
Z-2893-2016Class IIZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity FJuly 29, 2016
Z-2896-2016Class IIZyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity FeeJuly 29, 2016
Z-2895-2016Class IIZyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity FeJuly 29, 2016
Z-1024-2013Class IIZ-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood June 13, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAAAugust 30, 2016
K140783HALO AMBULATORY INFUSION SYSTEMOctober 17, 2014
K132841ZYNO MEDICAL ADMINISTRATION SETJanuary 23, 2014
K130690Z-800 INFUSION SYSTEMJune 12, 2013
K120685ZYNO MEDICAL ADMINISTRATION SETSeptember 7, 2012
K100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800July 8, 2010
K071545Z-800 VOLUMETRIC INFUSION PUMPOctober 31, 2007