Zyno A2-80072Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10814371020119), received between Jan 9, 2017 and Oct 13, 2021 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE 105" ADMIN SET 20 DP, W/2 Y SITE, CV WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT AN ADMINISTRATION SET MODEL A2-80072 LOT 20016342 WOULD NOT PRIME. OPERATOR RN. MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625963 ↗
• MalfunctionAug 18, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 3 105" ADMIN SETS 20 DP, W/2 Y SITE, CV HAD FLOW ISSUES AND WERE BLOCKED/OCCLUDED WHILE PRIMING THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED AN EMAIL STATED THAT AN ADMINISTRATION SET MODEL A2-80072 LOT 20095073 SET WOULD NOT PRIME. OPERATOR RN. MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340466 ↗
• MalfunctionJul 19, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED A LEAKING ISSUE WITH THE ADMINISTRATION SET. ON (B)(6) 2017 THE SET LEAKED AT MALE LUER LOCK ADAPTOR. THE SOLUTION USED FOR THE INFUSION WAS NS. THE TUBING HAD BEEN PRIMED, WHEN THE NURSE CONNECTED IT TO THE PATIENT, SHE IMMEDIATELY NOTED LEAKAGE SO STOPPED THE INFUSION. THE PATIENT WAS NOT ADVERSELY AFFECTED, AND THE TUBING WAS CHANGED WITHOUT FURTHER PROBLEMS WITH LEAKAGE. NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725204 ↗
• MalfunctionMar 24, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED THAT THE IV SETS WERE LEAKING FROM BOTTOM OF DRIP CHAMBER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6432712 ↗
• MalfunctionMar 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00070).

  Patient problems: Not Applicable

  MAUDE report 6379119 ↗
• MalfunctionFeb 24, 2017Split; Device Operates Differently Than Expected; Split; Device Operates Differently Than Expected

  THE USER REPORTED THAT "WE WENT TO INFUSE A PATIENT WITH TYSABRI ON ONE OF OUR ZYNO PUMPS. THE PUMP SET HAD A SPLIT IN THE ACTUAL TUBING AND THE MEDICATION SPILLED OUT ON THE FLOOR OF THE CLEAN ROOM." ON THE FOLLOW-UP CALL WITH A ZYNO CUSTOMER SERVICE EMPLOYEE, THE CUSTOMER MENTIONED THAT THE IV SET WAS LEAKING IN THE MIXING ROOM AND WAS NEVER PLACED IN THE PUMP. NO PATIENT INJURY OR HARM OCCURRED FOR THIS INCIDENT.

  Patient problems: Not Applicable

  MAUDE report 6358440 ↗
• MalfunctionFeb 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE USER REPORTED A LEAKING ISSUE THAT "HAPPENED AT THE VERY END OF THE TREATMENT (VERY SMALL LEAK) WITH NO INJURIES." THE LEAKAGE HAPPENED THROUGH THE TUBING ITSELF WHERE THE TUBING ENTERED AND EXITED THE INFUSION PUMP. THE MEDICATION INFUSED WAS PERJETA (NON-CHEMO). THE USER INFORMED A ZYNO CUSTOMER SERVICE EMPLOYEE THROUGH EMAIL THAT THE TUBING WAS IN THE SHARPS CONTAINER AND THUS WOULD NOT BE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6329839 ↗
• MalfunctionFeb 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00024).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304802 ↗
• MalfunctionFeb 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00021).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304792 ↗
• MalfunctionFeb 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00006).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304672 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE TUBING CAME APART AT THE DRIP CHAMBER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247813 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER REPORTED THAT "LEAKING FROM THE TUBING AND WHITE TAPE WAS NOT STICKY ENOUGH TO HOLD ROLLED TUBING IN PLACE". NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247811 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER STATED THAT THE TUBING SEPARATED FROM THE DRIP CHAMBER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247806 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER STATED THAT THE TUBING SEPARATED FROM THE DRIP CHAMBER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247803 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE TUBING WAS SEPARATED FROM THE DRIP CHAMBER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247797 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER STATED THAT THE TUBING HAD FLUID BACKING UP INTO SECONDARY (TUBING). NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247796 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED LEAKING BELOW THE UPPER Y-SITE OF THE IV SET. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247652 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER REPORTED THAT "TUBING COMES APART AT DRIP CHAMBER." THIS OCCURRED ON TWO SEPARATE OCCASIONS. THE ORIGINAL WAS NOT KEPT. THE MOST RECENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247571 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER REPORTED THAT THERE WAS A HOLE IN THE PRIMARY IV SET. THE USER STATED THAT " SOME SETS IN THIS LOT ARE CRIMPED AND IT APPEARS THAT IS CAUSING THE HOLE IN THE ONE SET. THE SETS WERE QUITE TWISTED IN THE PACKAGING." NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247569 ↗
• MalfunctionJan 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED A BACK CHECK VALVE FAILURE. "THE NURSE SQUEEZED THE PRIMARY SALINE BAG TO BACK PRIME THE SECONDARY DRUG BAG. WHEN THE NURSE LET GO OF THE PRIMARY BAG, THE FLUID IN THE SECONDARY BAG BACKED UP IN THE PRIMARY IV SET." THE USER "ALSO HAD TWO BACK CHECK VALVE FAILURE LAST WEEK." NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6234094 ↗
• MalfunctionJan 9, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER REPORTED "LEAKING AT THE DRIP CHAMBER" FOR THE IV SET. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6234090 ↗
• MalfunctionJan 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  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 6233071 ↗

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-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-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-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