Zyno BX-70072Recalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below 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
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00814371020570), received between Aug 23, 2019 and Jul 11, 2024 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (11 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
- Mechanical Problem11
- Air/Gas in Device1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Mechanical Problem; Mechanical Problem
ON 06/18/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT THEY WERE EXPERIENCING MULTIPLE FAILURES WITH THE TUBING WHEN RUNNING PROPOFOL THROUGH THE PUMP. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726449 ↗MalfunctionJun 30, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19640929 ↗MalfunctionJun 25, 2024Mechanical Problem; Air/Gas in Device; Mechanical Problem; Air/Gas in Device
ON (B)(6) 2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605988 ↗MalfunctionJun 24, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601201 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581859 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER REPORTING THE FILTER DOOR ON THE DRIP CHAMBER WAS FALLING OFF WHEN OPENING IT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581710 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581696 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT ON 2 SEPARATE OCCASIONS WITH 2 DIFFERENT NURSES THE CONNECTION PIECE ON THE PRIMARY ZYNO TUBING HAD BECOME DISCONNECTED WHEN TRYING TO REMOVE THE TUBING FROM THE PATIENTS IV LINE. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581158 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT THE GREEN FILTER INSERT (WHICH HAD THE FILTER COVER ON IT) ABOVE THE CHAMBER WAS NOT SECURED IN ANY WAY AND COULD BE PULLED OUT EASILY. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580951 ↗MalfunctionJun 20, 2024Mechanical Problem; Mechanical Problem
ON (B)(6) 2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER THAT WHEN PRIMING THE TUBING EVEN AFTER BEING CAREFULLY IT GENERATES A LOT OF AIR BUBBLES. THE NURSE REPORTED THAT 4 PUMPS HAD ALLOWED THE AIR PAST THE PUMP CHAMBER. FORTUNATELY, THE PUMP BEEPED THAT THE INFUSION WAS COMPLETES BEFORE AIR GOT TO THE PATIENT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578437 ↗MalfunctionJun 7, 2024Mechanical Problem; Mechanical Problem
ON 05/22/2024, ZYNO RECEIVED A REPORT FROM A CUSTOMER REGARDING ITEM BX-70072 LOT 2207006 THAT AT THE LUER LOCK CONNECTION, IT SEEMED TO DISCONNECT FROM THE ADMIN SET AND THEN SPIN FREELY. NO PATIENT INVOLVED OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487338 ↗MalfunctionAug 23, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
ON (B)(6) 2019, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A DISTRIBUTOR. THE DISTRIBUTOR STATED THAT A USER FACILITY REPRESENTATIVE REPORTED THAT "AN ADMINISTRATION SET MODEL BX-70072 LOT # 1810010 WAS LEAKING FROM THE BOTTOM JOINT OF THE DRIP CHAMBER". NO PATIENT HARM OR INJURY WAS INVOLVED. THE DEVICE OPERATOR WAS A RN. THE MEDICATION BEING INFUSED WAS IRON. THE USER FACILITY REPRESENTATIVE STATED THE AFFECTED SET HAD BEEN DISCARDED AND SHE WOULD SEND IN 5 SAMPLE SETS FROM THE SAME BOX AND LOT FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8925840 ↗
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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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