Zyno AA-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 AA 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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814371020600), received between May 11, 2017 and Jan 9, 2019 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (8 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
- Device Operates Differently Than Expected8
- Fluid/Blood Leak4
- Free or Unrestricted Flow4
- Leak/Splash3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient2
- No Information1
- Not Applicable1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2019. THE DISTRIBUTOR RECEIVED AN EMAIL FROM THE INITIAL REPORTER ON (B)(6) 2019, STATING THAT THE ADMINISTRATION SET TUBING WAS LEAKING FROM THE AIR VENT ON THE DRIP CHAMBER. THE MEDICATION BEING INFUSED WAS DOXORUBICIN. THERE WAS NO PATIENT INJURY AND NO PATIENT INFORMATION WAS PROVIDED TO ZYNO MEDICAL. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS AMSINO INTERNATIONAL INC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8232393 ↗MalfunctionJan 9, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2019. THE DISTRIBUTOR RECEIVED AN EMAIL FROM THE INITIAL REPORTER ON (B)(6) 2019, STATING THAT THE ADMINISTRATION SET TUBING WAS LEAKING FROM THE AIR VENT ON THE DRIP CHAMBER. THE MEDICATION BEING INFUSED WAS DOXORUBICIN. THERE WAS NO PATIENT INJURY AND NO PATIENT INFORMATION WAS PROVIDED TO ZYNO MEDICAL. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8232389 ↗MalfunctionDec 24, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(4) 2018. THE DISTRIBUTOR RECEIVED AN EMAIL ON (B)(4) 2018, STATING THAT "UPON STARTING EMEND, FLUID NOTED TO BE DRIPPING FROM IV TUBING VENT. CLOSED VENT AND INFUSION COMPLETED WITH NO FURTHER ISSUES." NO PATIENT INJURY WAS REPORTED IN THIS CASE. (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8194300 ↗MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00292).
Patient problems: No Information
MAUDE report 6996359 ↗MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material; Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material
THEY REPORTED THAT THERE WAS A FOREIGN OBJECT FOUND INSIDE THE ADMINISTRATION SET DRIP CHAMBER. "I HAD AN ISSUE WITH THE ZYNO TUBING WHILE PREPARING CHEMO. ONE OF THE MANY PROCESSES WE HAVE WHEN MIXING IS TO LOOK FOR PARTICULATES. I FOUND IN THE TUBING BEFORE I SPIKED THE BAG A LITTLE CRITTER! A BUG WAS INSIDE THE CHAMBER. I REPORTED TO THE RPH (B)(6). I AM NOT SURE WHAT ELSE TO DO AND I HAVE BEEN CHECKING ALL THE TUBING AND HAVEN'T COME ACROSS ANYTHING ELSE. I DID SAVE THE TUBING IN A BAG AWAY FROM CLEAN ITEMS. " THE EVENT DATE REPORTED BY THE USER WAS (B)(6) 2017. NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6857583 ↗MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED AN ISSUE IN WHICH "THE SECONDARY SET IS ALLOWING SOLUTION TO PASS WHEN THE ROLLER CLAMP IS CLOSED". THE USER REPORTED THAT "IT SEEMS, AND I DID WITNESS THIS, THAT EVEN WHEN THE CLAMP ON THE TUBING IS CLOSED, ONCE THE BAG HAS BEEN SPIKED, THE MEDICATION (WHATEVER IS IN THE BAG) STARTS DRIPPING. AGAIN, THIS IS OCCURRING EVEN THOUGH THE ROLLER CLAMP IS CLOSED. ALL OF THESE INCIDENTS, WHICH SHE SAID HAVE BEEN WITH JUST ABOUT EVERY SET SHE HAS USING OVER THE LAST FEW WEEKS, ARE FROM LOT# 107272-KS. PATIENT WAS NOT DIRECTLY INVOLVED AND THERE WERE NO INJURIES. ISSUE WAS NOTICED WHEN TUBING WAS CONNECTED TO RESERVOIR. (I) DO NOT KNOW EXACT DATE BUT SHE STATED THAT IT HAD BEEN OCCURRING FOR THE LAST FEW DAYS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6857576 ↗MalfunctionJul 19, 2017Device Operates Differently Than Expected; Free or Unrestricted Flow; Device Operates Differently Than Expected; Free or Unrestricted Flow
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00244).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6725213 ↗MalfunctionJul 6, 2017Device Operates Differently Than Expected; Free or Unrestricted Flow; Device Operates Differently Than Expected; Free or Unrestricted Flow
THE USER REPORTED AN ISSUE WITH THE IV SET ROLLER CLAMP. "WE HAVE BEEN HAVING AN ISSUE WITH SOME OF OUR SECONDARY TUBING. THE BLUE CLAMP, WHEN ROLLED DOWN TO THE CLOSED POSITION, IS STILL ALLOWING FLUID TO PASS. WE STARTED NOTICING THIS LAST WEEK. IT WAS NOTICED BY OUR TECHNICIANS WHEN ATTACHING THE TUBING TO AN IVPB. IT ISN'T HAPPENING EVERY TIME, ONLY OCCASIONALLY. WE STARTED TO NOTICE THIS ON (B)(6)2017 AND IT HAS HAPPENED ON SEVERAL OCCASIONS SINCE THEN. WE DID NOT KEEP THE IV SET BUT WILL DO SO IF WE RUN ACROSS ANOTHER." THE SOLUTION USED WAS SALINE WHEN THE ISSUE WAS OBSERVED. NO PATIENT WAS INVOLVED IN THIS CASE.
Patient problems: Not Applicable
MAUDE report 6690549 ↗MalfunctionJun 15, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00231).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6645311 ↗MalfunctionJun 15, 2017Device Operates Differently Than Expected; Free or Unrestricted Flow; Device Operates Differently Than Expected; Free or Unrestricted Flow
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00232).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6645310 ↗MalfunctionMay 11, 2017Device Operates Differently Than Expected; Free or Unrestricted Flow; Device Operates Differently Than Expected; Free or Unrestricted Flow
THE USER REPORTED THAT AN IV SET LEAKING ISSUE. THE SOLUTION PASSED THROUGH THE CLOSED ROLLER CLAMP ON THE SECONDARY LINE. "WE HAVE HAD A DISASTER HERE THE PAST COUPLE OF DAYS WITH OUR SECONDARY TUBING! PROBABLY HALF OF OUR TUBINGS ARE STILL POURING LIQUID THROUGH THE TUBING, AND UPON CLOSER INSPECTION IT APPEARS THAT IF YOU ROLL THE ROLLER TO A CERTAIN SPOT IT CLOSES THE LINE, BUT IF YOU ROLL IT ALL THE WAY UP IT RELEASES THE TUBE AND FLOWS AGAIN...SO, WE HAVE HAD CHEMOTHERAPY, STEROIDS, SALINE, AND ALL KINDS OF OTHER MEDS POURING ONTO OUR COUNTERS AND FLOORS. WE AT FIRST THOUGHT IT WAS SOMEONE FORGETTING TO CLAMP THE TUBES, BUT THEN TODAY WE REALLY KET AN EYE ON IT AND DISCOVERED THE MESS! I JUST WANTED TO LET YOU KNOW, AND WE'RE HOPING THAT IT WAS JUST ONE BOX OF SECONDARY TUBES AND NOT ALL WE HAVE IN STOCK!!" NO PATIENT WAS INJURED OR HARMED IN THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6560039 ↗
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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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