Zyno A2-80072-FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10814371020126), received between Jan 6, 2017 and Feb 7, 2018 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  A DISTRIBUTOR FORWARDED AN MESSAGE FROM A REPRESENTATIVE AT THE USER FACILITY REPORTED A LEAKING ISSUE WITH THE DEVICE TO ZYNO MEDICAL ON (B)(6) 2018: "WE HAD AN INCIDENT WHERE THE CHEMOTHERAPY WAS LEAKING FROM THE FILTER PART OF THE TUBING. PATIENT NOTICED LEAKING BUT WAS NOT EXPOSED EXTERNALLY FROM LEAKAGE. NO INJURIES TO PATIENT OR STAFF. LEAKING JUST AT THE FILTER SITE AND YES APPROXIMATELY 200 CC WAS DELIVERED TO PATIENT IV ALREADY." THE EVENT DATE WAS "(B)(6) 2018" AND THE SOLUTION USED DURING THE EVENT WAS "ETOPOSIDE IN 50 CC NSS OVER 1 HOUR". THE AFFECTED SET WAS CAPTURED AT THE USER FACILITY AND WILL BE RETURN TO ZYNO MEDICAL FOR INVESTIGATION. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247348 ↗
• MalfunctionJan 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT "WE JUST HAD A CHEMO LEAK WITH TAXOL. THE LAST PART OF THE MEDICATION IN THE BAG BEGAN TO LEAK AT THE POINT WHERE THE SPIKE IS IN THE BAG. NO HARM TO NURSE OR PATIENT THAT WE ARE AWARE OF. MY THOUGHTS ARE THAT THE TAXOL SOMEHOW ERODED THE PLASTIC WHICH CAUSED THE SEAL TO BE BROKEN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247634 ↗
• MalfunctionJan 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2016-00013).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6230398 ↗

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-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
• 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