Zyno AX-80071-DF-120Recalls & reported problems
Zyno Medical LLC · AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 1.2 Filter, Pinch Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814371020464), received between Aug 8, 2022 and Aug 8, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON 08/01/2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182764 ↗MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON 07/27/2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON 08/01/2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182763 ↗MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON 07/27/2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON 08/01/2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182759 ↗MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON (B)(6) 2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182757 ↗MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON (B)(6) 2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182756 ↗MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. 6 ADMINISTRATION SETS WERE REPORTED TO HAVE FILTER TUBING MALFUNCTION: "IT STARTS LEAKING SIGNIFICANTLY FROM THE FILTER PORTION." THE REPORTER STATED THAT THIS SEEMS TO HAPPEN WHEN THEY NEED TO PAUSE THE THERAPY THAT'S RUNNING AND THEN RESTART IT. THE THERAPY WAS A TPN CONTAINING LIPIDS. DEVICE OPERATOR WAS A CPHT. MEDICATION BEING INFUSED WAS LIPIDS. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. ON 08/01/2022, THE USER FACILITY REPRESENTATIVE CONTACTED ZYNO MEDICAL AND REPORTED THAT "GREAT NEWS, THIS ISSUE WE WERE TOLD ABOUT LAST WEEK WAS A NURSING ERROR. MY CONTACT JUST EMAILED ME THAT THE NURSE WAS NOT CONNECTING EVERYTHING RIGHT CAUSING AN ERROR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15182755 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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