Zyno BX-70071-DF-120Recalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 1 NF Y Site Below Pump, 1.2 Filter, 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
- 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 00814371020556), received between May 20, 2024 and May 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Contamination; Contamination
ON 05/02/2024, ZYNO RECEIVED A REPORT FROM A CUSTOMER WHOM HAD PURCHASED AX-80075 LOT 2302002 AND BX-70071-DF LOT 2309023 FROM INFUSYSTEM, THEY STATED THEY FOUND HAIRS INSIDE THE TUBING BAGS. THE CUSTOMER WAS GOING TO BE RETURNING THE REMAINING STOCK OF THESE TWO LOTS TO INFUSYSTEM. ZYNO MEDICAL HAS QUARANTINED ANY OF THE REMAINING STOCK OF THESE LOTS. ZYNO MEDICAL, IS ATTEMPTING TO OBTAIN THE ACTUAL SAMPLES TO SEND IN FOR AN INVESTIGATION. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355100 ↗
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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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