Zyno AX-80071-DRecalls & reported problems
Zyno Medical LLC · AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Roller Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814371020440), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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 Expected1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected
A RN AT A USER FACILITY REPORTED A LEAKING ISSUE AT THE DRIP CHAMBER OF THE ADMINISTRATION SET ON (B)(6) 2018. APPROXIMATELY 5 SETS EXPERIENCED THE ISSUE OF LEAKING AT THE DRIP CHAMBER NEAR THE BOTTOM WHERE IT CONNECTS TO THE TUBING SINCE (B)(6) 2018. NO AFFECTED SET WAS CAPTURED AND ALL AFFECTED SETS WERE DISPOSED BY A NURSE THAT EXPERIENCED THIS ISSUE. MEDICATIONS USED DURING THIS INCIDENT WERE NS, TYFABRI AND OCREVUS. THE CONTRACT MANUFACTURER OF THE ADMINISTRATION SET IS (B)(4). NO PATIENT JURY OR HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7480636 ↗
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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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