Zyno A2-80071-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10814371020065), received between Jan 9, 2017 and Jun 15, 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.

• MalfunctionJun 15, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THIS IS THE SECOND FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00222).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645288 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE IV SET TUBING WAS SEPARATED AT THE BOTTOM OF THE DRIP CHAMBER. HERE ARE DETAILS OF EVENT " TO RECAP, LEVOLEUCOVORIN (FUSILEV) 800MG WAS PLACED IN A 250ML NS BAG WITH SINGLE PORT TUBING TO RUN WITH OXALIPLATIN SIMULTANEOUSLY, AS TYPICAL PROCESS. WHEN THE NURSE PLACED THE BAG ONTO THE HOOK, THE TUBING FELL AWAY FROM THE DRIP CHAMBER, CAUSING A SPILL ONTO THE NURSE, PATIENT AND FLOOR. THE NURSE QUICKLY REMOVED THE BAG FROM THE POLE AND INVERTED, BRINGING IT BACK TO THE PHARMACY AND THEN PROCEEDED TO ADDRESS THE PATIENT, HERSELF AND THE SPILL, PER PROTOCOL.. THE NURSING AND PHARMACY STAFFS ARE CONCERNED GOING FORWARD WITH THE QUALITY OF THE TUBING. WE HAD PROBLEMS LAST WEEK WHEN I SPOKE WITH (B)(4) REGARDING STRETCHING OF SECONDARY TUBING AT THE CHAMBER (A2-80075).....WE DO HAVE SOME CONCERNS AND WILL USE EXTRA CAUTION IN WORKING WITH YOUR PRODUCT." NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247857 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED AN ISSUE OF THE IV SET. "LEAKING FROM THE CHAMBER AND CREATING A VACUUM THAT COLLAPSED THE CHAMBER AND WAS PULLING BLOOD OUT OF THE PATIENT INTO THE CATHETER". NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247843 ↗
• MalfunctionJan 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER COMPLAINED ABOUT TUBING LEAKAGE ON (B)(6) 2014. HE STRUGGLED TO EXPLAIN THE PROBLEM, BUT IT SOUNDED LIKE HE WAS TALKING ABOUT "THE TUBING LEAKING CHEMO FROM THE END OF THE TUBING EVEN IF THEY ARE FULLY ENGAGED THE ROLLER CLAMP AND THE SLIDE CLAMP". OUR COMPLAINT TEAM FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2014, AND THE CONVERSATION REVEALED THAT "THERE WAS NO LEAKING BUT FLUID WAS COLLECTING IN THE CAP ON THE LUER LOCK". THE ACTUAL FAILED IV SET WAS NOT CAPTURED BY THE CUSTOMER. THE CUSTOMER RETURNED SOME UNOPENED IV SET FROM THE LOTS HE BELIEVED HAD THE ISSUES. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233044 ↗

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-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-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