Zyno BX-70072-FRecalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814371020587), received between Dec 5, 2025 and Mar 20, 2026 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Device Contaminated During Manufacture or Shipping
A CUSTOMER REPORTED THAT DURING A PHARMACIST INSPECTION, WHAT APPEARED TO BE A HAIR WAS IDENTIFIED INSIDE A SEALED ADMINISTRATION SET PACKAGE. THE PRODUCT WAS UNOPENED AT THE TIME OF DISCOVERY. NO ADVERSE EVENT OR PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654771 ↗MalfunctionJan 6, 2026Leak/Splash
FOR LOT 2502043, THE CUSTOMER REPORTED TWO ADDITIONAL LEAKING ADMINISTRATION SETS ON (B)(6) 2025. THE CUSTOMER PROVIDED A VIDEO DOCUMENTING THE ISSUE, WHICH SHOWED FLUID LEAKING FROM BELOW THE DRIP CHAMBER. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED AT THE TIME OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980310 ↗MalfunctionDec 5, 2025Leak/Splash; Leak/Splash
INTUVIE RECEIVED REPORTS OF LEAKING BX-70072-F IV SETS FROM LOT 2502043. THE CUSTOMER PROVIDED IMAGES CONFIRMING LEAKAGE AT THE BONDED JOINT BELOW THE DRIP CHAMBER. THE CUSTOMER STATED THIS IS THE FIRST LOT IN WHICH THEY HAVE EXPERIENCED THIS ISSUE. NO ADVERSE EVENT OR PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23731981 ↗
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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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