Zyno A2-80075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10814371020133), received between Jan 9, 2017 and Apr 14, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED A SECONDARY SET ISSUE THAT THE ROLLER CLAMP DID NOT CLOSE THE LINE LEADING TO FREE-FLOW. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6494725 ↗
• MalfunctionFeb 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED THAT THEY WERE "HAVING AN ISSUE WITH THE TUBING SETS LEAKING EVEN THOUGH THEY ARE CLAMPED" AND "THEY ARE LEAKING BEFORE GETTING TO THE PUMPS". HE ALSO REPORTED THAT "THIS IS HAPPENING WITH ALL THREE SETS THAT WE USE" AND HE HAS "CLOSED ALL CLAMPS ON THE PRIMARY LINES AND IT STILL LEAKS". NO PATIENTS WERE INVOLVED AND VARIOUS MEDICATIONS WERE USED.

  Patient problems: Not Applicable

  MAUDE report 6329912 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT "THE TUBING CAME OFF THE DRIP CHAMBER", AND "FORTUNATELY THERE WAS WATER IN THE BAG WHICH WENT EVERYWHERE WHEN THE TUBING CAME OFF AND NOT CHEMO". NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247823 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER IS CONSISTENTLY GETTING 4-5 SETS PER BOX THAT ARE FREE FLOWING AT THE SECONDARY CONNECTION. THEY THINK IT'S A PROBLEM WITH THE UPPER Y-SITE ON THE PRIMARY SET, BUT IT MIGHT BE SOMETHING WITH THE SECONDARY SET. THERE WAS NO PATIENT INJURY OR HARM INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233105 ↗

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-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-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-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
• 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-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