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Zyno A2-80071-DF120Recalls & reported problems

Zyno Medical LLC · A2 Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 1.2 Filter, Pinch Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 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
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10814371020089), received between Jan 6, 2017 and Sep 23, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K132841); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Leak/Splash4
  • Fluid/Blood Leak2
  • Device Operates Differently Than Expected1
  • Material Integrity Problem1
  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient4
  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2022Leak/Splash; Leak/Splash

    ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE: "WE'VE HAD A FEW MISHAPS THIS WEEK WITH ZYNO PRODUCTS MID-INFUSION WHERE THE DRUG HAS LEAKED OUT OF THE FILTERS AND ALL OVER THE PATIENTS; MEANING THE DOSES ARE REQUIRED TO BE THROWN AWAY AS THEY ARE NO LONGER USABLE." THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS UNKNOWN. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15473523 ↗
  • MalfunctionSep 23, 2022Leak/Splash; Leak/Splash

    ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE: "WE'VE HAD A FEW MISHAPS THIS WEEK WITH ZYNO PRODUCTS MID-INFUSION WHERE THE DRUG HAS LEAKED OUT OF THE FILTERS AND ALL OVER THE PATIENTS; MEANING THE DOSES ARE REQUIRED TO BE THROWN AWAY AS THEY ARE NO LONGER USABLE." THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS UNKNOWN. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15473286 ↗
  • MalfunctionSep 23, 2022Leak/Splash; Leak/Splash

    ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE: "WE'VE HAD A FEW MISHAPS THIS WEEK WITH ZYNO PRODUCTS MID-INFUSION WHERE THE DRUG HAS LEAKED OUT OF THE FILTERS AND ALL OVER THE PATIENTS; MEANING THE DOSES ARE REQUIRED TO BE THROWN AWAY AS THEY ARE NO LONGER USABLE." THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS UNKNOWN. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15472966 ↗
  • MalfunctionFeb 27, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

    AN IV CLINICAL PHARMACIST AT THE USER FACILITY REPORTED AN LEAKING ISSUE WITH THE ADMINISTRATION SET TPN FILTER TO ZYNO MEDICAL ON (B)(6) 2018: "WE HAVE 1 MORE DEFECTIVE TPN FILTER TUBING. I WILL SEND IT TO YOU AS SOON AS WE GET IT FROM NURSING FACILITY." THE REPORTER ALSO ATTACHED A VIDEO "THAT NURSE RECORDED AT THE FACILITY WHILE ADMINISTERING TPN TO A PATIENT" AND INDICATED THAT "YOU CAN SEE WHERE THE LEAKAGE IS HAPPENING." THE DISTRIBUTOR FOR THIS USER FACILITY PROVIDED ADDITIONAL INFORMATION TO ZYNO MEDICAL ON 02/19/2018 THAT "FYI. IT TURNS OUT THEY ARE INFUSING LIPIDS THRU A .2 MICRON FILTER, NOT A 1.2 MICRON FILTER. THIS IS AN EXAMPLE OF WHERE THE ACCOUNT WAS IN CLEAR ERROR." THE CLINICAL DIRECTOR AT ZYNO MEDICAL DISCOVERED THIS ISSUE ON THE VIDEO AS THE LEAKAGE LOOKED LIKE LIPIDS, AND IT WAS CONFIRMED BY THE RESPONSE OF THE USER FACILITY. THIS INFORMATION HAS BEEN RELAYED TO THE LEAD CLINICIAN AT THE USER FACILITY. THE IV CLINICAL PHARMACIST AT THE USER FACILITY REPORTED TO ZYNO MEDICAL ON 02/20/2018 THAT A SAMPLE WOULD BE SENT TO ZYNO MEDICAL: "WE WILL BE SENDING OUT AN USED/DEFECTIVE TPN 1.2MICRON FILTER TUBING. LOT#:16095981 EXP: 09/2019". NO PATIENT INJURY OR HARM WAS R

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7299974 ↗
  • MalfunctionApr 7, 2017Material Integrity Problem; Material Integrity Problem

    THE USER REPORTED A TUBING SEPERATION ISSUE OF THE IV SET DURING INFUSION. THE TUBING DISCONNECTED FROM THE FILTER HOUSE. NO PATIENT HARM OR INJURY WAS INVOLVED IN THIS CASE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6472422 ↗
  • MalfunctionJan 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

    THE USER REPORTED "THE IV SET CAME APART FROM THE FILTER AND LEAKED FLUID OVER A SURGE PROTECTOR/OUTLET STRIP. THE SURGE PROTECTOR/OUTLET STRIP WAS DAMAGED AND ALMOST CAUSED A FIRE. A PATIENT WAS INVOLVED BUT THERE WAS NO ADVERSE EFFECT."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6230446 ↗
  • MalfunctionJan 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

    THE USER REPORTED "FILTERED TUBING LEAKING AT THE FILTER. THIS IS THE SECOND TIME AS THE FIRST CAUSED THE PATIENT TO MISS OVER HALF OF THEIR INFUSION BEFORE WE REALIZED THIS WAS OCCURRING, NOW THIS; A BAG OF FLUIDS LEAKED ONTO PATIENT'S SHIRT."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6230399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132841. One submission often covers many models, so check the product and lot details in each record.

  • Z-2058-2019 · May 29, 2019 · Terminated
    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
  • Z-2059-2019 · May 29, 2019 · Terminated
    Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
  • Z-2894-2016 · Jul 29, 2016 · Terminated
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a d
  • Z-2896-2016 · Jul 29, 2016 · Terminated
    Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a de
  • Z-2893-2016 · Jul 29, 2016 · Terminated
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Pro
  • Z-2895-2016 · Jul 29, 2016 · Terminated
    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Pro

Other Set, Administration, Intravascular devices

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Sources and updates

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