Zyno A2-80070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10814371020058), received between Jan 11, 2017 and Jun 1, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected; Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected

  ZYNO MEDICAL WAS NOTIFIED OF A LEAKING ISSUE ON (B)(6) 2018 FROM THE DISTRIBUTOR. THE USER'S DESCRIPTION OF THE INCIDENT WAS FORWARDED TO ZYNO MEDICAL AND IS AS FOLLOWS: "CARBOPLATIN TUBING BEGAN TO LEAK. UPON FURTHER INVESTIGATION, THE TUBING APPEARED TO BE SLICED OR CUT. CHEMO WASTED TO THE FLOOR AND TWO SMALL DOTS LANDED ON THE PATIENT'S HAND AND FOREARM. THE AREAS ON THE PATIENT WERE CLEANED WITH WARM WATER AND SOAP. THE FLOOR WAS CLEANED USING BLEACH WIPES. THE ENTIRE BAG OF CARBOPLATIN AND TUBING WAS REPLACED BY PHARMACY". THE DRUG BEING INFUSED WAS CARBOPLATIN. THERE WAS A DELAY IN DELIVERY DUE TO THE INCIDENT AND CHEMO WAS SPILLED ON THE FLOOR. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE. THE DATE OF THE EVENT IS (B)(6) 2018. THE LOT NUMBER REPORTED WAS "16035518 OR 17106197". THE CONTRACT MANUFACTURE OF THE AFFECTED SET IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7562523 ↗
• MalfunctionMar 24, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED A LEAKING ISSUE WITH IV SETS FROM THE GREEN VENT VALVE. "WE INFUSE PRIMARILY BIOLOGIC MEDICATIONS. THE ISSUES HAVE HAPPENED ON VARIOUS DIFFERENT PRODUCTS, EACH RUNNING AT DIFFERENT RATES. WE'VE HAD A NUMBER OF INSTANCES WHERE THE SET STARTED LEAKING WHILE TRYING TO PRIME THE SET PRIOR TO STARTING AN INFUSION. SOME HAVE LEAKED AFTER THE INFUSION STARTS AND THEN OTHERS HAVE STARTED LEAKING THREE HOURS INTO A PATIENT'S INFUSION". NO PATIENT HARM OR INJURY WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432749 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED AN ISSUE WITH THE IV SET THAT "LEAKING FROM DRIP CHAMBER VENT". NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247863 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED AN ISSUE WITH AN IV SET: "WHEN OPENED HAD NO CAP ON THE SPIKE". NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247848 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER REPORTED THAT "LEAKING AT DRIP FROM VENTED PORT" FOR THE IV SET. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247564 ↗
• MalfunctionJan 11, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE USER REPORTED THAT "I'VE HAD TO PULL A TOTAL OF 1305 ADMIN SETS OUT OF USE (A2-80070) BECAUSE WE HAVE HAD SEVERAL OF THE SETS (LOT 1606002) LEAK DURING INFUSION." PATIENTS WERE INVOLVED BUT NO INJURY OR HARM. THE LEAKING CAME FROM THE GREENISH PORT (AIR VENT) JUST UNDER THE SPIKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6244079 ↗

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-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-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-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