Zyno BX-70070Recalls & reported problems
Zyno Medical LLC · BX Primary Administration Set: 105" Straight Line Set, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814371020525), received between Apr 18, 2018 and Feb 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Device Operates Differently Than Expected1
- Fluid/Blood Leak1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Leak/Splash
IT WAS REPORTED TO INTUVIE THAT THREE IV TUBING SETS (ITEM: BX-70070) FROM LOT NUMBER: 2502048 (EXPIRATION DATE: 02/28/2028) LEAKED FROM AN AREA BELOW THE DRIP CHAMBER IMMEDIATELY UPON REMOVAL FROM THE PACKAGING. THE THREE TUBING SETS WERE FROM THE SAME BOX. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404848 ↗MalfunctionDec 31, 2025Leak/Splash; Leak/Splash
THE INFUSION SPECIALIST REPORTED TO INTUVIE THAT SEVERAL BX-70070 ADMINISTRATION SETS FROM LOT #2502046 APPEARED TO BE DEFECTIVE. THE REPORTER EXPERIENCED TWO ISSUES ON FRIDAY MORNING AND ONE ISSUE THE PREVIOUS THURSDAY. THE BOX WAS FIRST OPENED THE DAY PRIOR TO REPORTING. THE ADMINISTRATION SETS WERE OBSERVED TO BE LEAKING FROM THE BOTTOM OF THE DRIP CHAMBER. NO PATIENT OR USER HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933982 ↗MalfunctionJan 16, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00001).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9597074 ↗MalfunctionApr 18, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected
ZYNO MEDICAL WAS NOTIFIED OF AN ADMINISTRATION SET LEAKING ISSUE ON 04/10/2018 FROM A DISTRIBUTOR: "MY CUSTOMER ONCOLOGY CONSULTANTS IS HAVING A LEAKING ISSUE AGAIN WITH THEIR TUBING SET BX-70070 EXCEPT THIS TIME IT IS LEAKING AT THE TOP OF THE DRIP CHAMBER. I AM GOING TO SEND YOU THE SET FOR FURTHER INVESTIGATION, AND JUST AN FYI THIS TUBING SET DID NOT HAVE CHEMO IN IT JUST SALINE". DURING THE FOLLOW-UP WITH THE DISTRIBUTOR REPRESENTATIVE, IT WAS CONFIRMED THAT THE PATIENT WAS CONNECTED TO THE INFUSION PUMP WHEN ISSUE WAS NOTICED, AND NO INJURIES WERE REPORTED. THE DISTRIBUTOR ALSO CONFIRMED THAT "PUMP HAD BEEN RUNNING FOR ABOUT 30 MINUTES WHEN TUBING LEAK WAS NOTICED. THE LEAKING HAPPENED AT THE TOP OF THE DRIP CHAMBER NEAR THE BAG SPIKE". THE LOT NUMBER OF THE AFFECTED SET IS 1606009.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7441179 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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