Zyno BX-70071-DFRecalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 1 NF Y-Site Below Pump, .22 Filter, Back Check-Valve, 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814371020549), received between Aug 6, 2024 and Sep 10, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash6
- Break4
- Contamination1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716267 ↗MalfunctionMar 25, 2026Material Puncture/Hole
INTUVIE RECEIVED A REPORT OF DEFECTIVE BX-70071-DF INTRAVENOUS (IV) SETS. THE REPORTER INDICATED THAT THERE IS A HOLE ABOUT 18" FROM THE BOTTOM OF THE TUBING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695166 ↗MalfunctionMar 25, 2026Leak/Splash
INTUVIE RECEIVED A REPORT OF DEFECTIVE BX-70071-DF INTRAVENOUS (IV) SETS. THE REPORTER INDICATED THAT THE IV SETS WERE LEAKING FROM THE BASE OF THE CHAMBER. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695161 ↗MalfunctionDec 9, 2025Contamination; Contamination
INTUVIE RECEIVED A REPORT FROM RIGHT WAY MEDICAL STATING THAT SYNCHRONY PHARMACY FOUND A HAIR ¿HALF INSIDE AND HALF OUTSIDE¿ IN THE STERILE PACKAGE OF ONE BX-70071-DF ADMINISTRATION SET FROM LOT 2502034. THE ISSUE WAS IDENTIFIED PRIOR TO USE, AND NO PATIENT INVOLVEMENT OR ADVERSE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759871 ↗MalfunctionAug 6, 2024Break; Leak/Splash; Break; Leak/Splash
THE CUSTOMER REPORTED ISSUES WITH THE TUBING BREAKING AND LEAKING. THERE WERE NO ADDITIONAL DETAILS PROVIDED, OR WHETHER THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921535 ↗MalfunctionAug 6, 2024Break; Leak/Splash; Break; Leak/Splash
THE CUSTOMER REPORTED ISSUES WITH THE TUBING BREAKING AND LEAKING. THERE WERE NO ADDITIONAL DETAILS PROVIDED, OR WHETHER THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921447 ↗MalfunctionAug 6, 2024Break; Leak/Splash; Break; Leak/Splash
THE CUSTOMER REPORTED ISSUES WITH THE TUBING BREAKING AND LEAKING. THERE WERE NO ADDITIONAL DETAILS PROVIDED, OR WHETHER THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921172 ↗MalfunctionAug 6, 2024Break; Leak/Splash; Break; Leak/Splash
THE CUSTOMER REPORTED ISSUES WITH THE TUBING BREAKING AND LEAKING. THERE WERE NO ADDITIONAL DETAILS PROVIDED, OR WHETHER THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919521 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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