Zyno AX-80075Recalls & reported problems
Zyno Medical LLC · Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40", Bag Hanger, Roller Clamp. Secondary Administration Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All AX Secondary 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814371020518), received between Sep 17, 2019 and May 20, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 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.
Reports received per month
Most reported problems
Device problems
- Contamination2
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Fluid/Blood Leak1
- Leak/Splash1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Contamination; Contamination
ON 05/02/2024, ZYNO RECEIVED A REPORT FROM A CUSTOMER WHOM HAD PURCHASED AX-80075 LOT 2302002 AND BX-70071-DF LOT 2309023 FROM INFUSYSTEM, THEY STATED THEY FOUND HAIRS INSIDE THE TUBING BAGS. THE CUSTOMER WAS GOING TO BE RETURNING THE REMAINING STOCK OF THESE TWO LOTS TO INFUSYSTEM. ZYNO MEDICAL HAS QUARANTINED ANY OF THE REMAINING STOCK OF THESE LOTS. ZYNO MEDICAL, IS ATTEMPTING TO OBTAIN THE ACTUAL SAMPLES TO SEND IN FOR AN INVESTIGATION. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355036 ↗MalfunctionApr 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ON (B)(6) 2024 INTUVIE RECEIVED A COMPLAINT VIA FDA'S MEDWATCH PROGRAM WHERE FDA ATTACHED THE MDR REPORT SUBMITTED BY THE INITIAL REPORTER FROM CANCER AND HEMATOLOGY CENTERS OF WESTERN MICHIGAN. MDR REPORT INDICATES THAT THE THERE IS A HAIR IN BAG NOTICED WHERE IT IS A STERILE PRODUCT. ALSO ADDITIONAL DOCUMENTS WERE ATTACHED FOR REFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19166813 ↗MalfunctionJan 10, 2022Contamination; Contamination
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00059).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13208391 ↗MalfunctionNov 10, 2021Nonstandard Device; Contamination /Decontamination Problem; Nonstandard Device; Contamination /Decontamination Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12790466 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
ON (B)(6) 2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT "(B)(6) HAS A LEAKING SECONDARY TUBING AX-80075 LOT NUMBER: 1807005. I AM RETURNING IT TO YOU, IT DOES HAVE CHEMO IN IT (DACARBAZINE). THE TUBING WAS LEAKING AT THE BLUE AIR VENT. IT HAPPENED (ON) (B)(6) 2019 AT 3:00 PM." NO PATIENT HARM OR INJURY INVOLVED. THE DISTRIBUTOR FOLLOWED UP FOR FURTHER INFORMATION (INCLUDING TO CLARIFY WHAT IS MEANT BY BLUE AIR VENT-- IS IT GREEN VENT ON THE DRIP CHAMBER? OR IS IT THE BLUE BACK CHECK VALVE?) AND IS AWAITING FOR A RESPONSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9078375 ↗
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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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