Zyno BX-70071-PRecalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 1 NF Y-Site Above Pump, 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814371020563), received between Feb 5, 2026 and Sep 18, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827533 ↗MalfunctionFeb 5, 2026Leak/Splash
A CUSTOMER REPORTED THAT THE ADMINISTRATION SET TUBING LEAKED IMMEDIATELY ONCE FLUIDS WERE INITIATED DURING INFUSION. ACCORDING TO NURSING STAFF, NO VISIBLE DEFECTS WERE OBSERVED ON THE TUBING PRIOR TO INFUSION. NO ADVERSE EVENT OR PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268971 ↗
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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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