Zyno B2-70071-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10814371020188), received between Feb 6, 2017 and Feb 20, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2018Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem; Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem

  A CERTIFIED PHARMACY TECHNICIAN AT THE USER FACILITY REPORTED AN OVER-INFUSION ISSUE TO ZYNO MEDICAL ON (B)(6) 2018. THE INCIDENT OCCURRED DURING ROUTINE POST CLEANING PUMP TESTING ON (B)(6) 2018 AND INVOLVED A B2-70071-P PRIMARY TUBING SET AND A Z-800F INFUSION PUMP. NO PATIENT WAS INVOLVED IN THIS CASE. THE FOLLOWING WAS REPORTED FROM THE INITIAL REPORTER: "I NEED TO REPORT A FLOW FAILURE OF A ZYNO PRIMARY TUBE SET PART # B2-70071-P LOT# 16117996 EXP 11-27-2019 PROPERLY INSTALLED IN A Z800-F PUMP ON OUR TEST BED UNIT WAS SET TO RUN 250 ML @ 167 ML / HOUR SHOULD HAVE TAKEN 1 HOUR 30 MINUTES TO COMPLETE BAG EMPTIED IN UNDER 30 MINUTES I HAVE VERIFIED PROPER INSTALLATION AND SET- UP OF THE PUMP A SECOND UNIT SET UP IDENTICALLY WITH THE SAME TUBING SET STARTED AT THE SAME TIME - APPEARS TO BE RUNNING PROPERLY I HAVE THE PACKAGING AND THE TUBE SET WITH THE IV BAG ATTACHED IF YOU WOULD LIKE TO COLLECT IT FOR TESTING PLEASE LET ME KNOW AS I AM VERY CONCERNED ABOUT THIS WE HAD A RUN OF SIMILAR TUBE FAILURES BEFORE - AND WHILE: TO MY KNOWLEDGE SO FAR THIS HAS NOT HAD PATIENT IMPACT... THE POTENTIAL FOR HARM IS VERY CLEARLY EVIDENT IN THIS PRODUCT FAILURE" ZYNO MEDICAL FOLLOWED UP WITH THE

  Patient problems: Not Applicable

  MAUDE report 7283544 ↗
• MalfunctionSep 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED TO A ZYNO MEDICAL SALES TERRITORY MANAGER ON (B)(6) 2016 THAT THEY EXPERIENCED AN ADMINISTRATION SET ISSUE: "I JUST EXPERIENCED AND INCIDENT WITH THE PRIMARY PUMP TUBING (WITH UPPER Y-PORT) WHEN DOING A DEMO FOR SOME STAFF. THE TUBING CAME OUT WITH THE "PINCH" CLAMP, CLAMPED, HOWEVER THE FLUID WAS FLOWING. I CHECK TO BE SURE THE TUBING WAS ACTUALLY CAUGHT AND IT WAS. I THEN SLID THE CLAMP TO ANOTHER SECTION OF TUBING AND AGAIN IT JUST FLOWED." NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6890042 ↗
• MalfunctionMar 24, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED THAT LEAKAGE OF AN IV SET OCCURRED PAST THE ROLLER CLAMP. "THIS TIME I HAD TESTED PUMPS AND THE TUBE LEFT HANGING, THE BAG ONLY HAD ABOUT 375ML REMAINING-WHICH ALL LEAKED OUT PAST THE 2 CLOSED CLAMPS". NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6432746 ↗
• MalfunctionMar 24, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED THAT LEAKAGE OF AN IV SET OCCURRED PAST THE ROLLER CLAMP. "THE BAGS WITH TUBING ATTACHED WERE HUNG WITH BOTH PUMP CLAMP AND LOWER ROLLER CLAMP CLOSED, AND OVERNIGHT ALL CONTENTS OF THE BAGS LEAKED PAST THE CLOSED CLAMPS AGAIN." IT IS AN ISSUE WITH ROLLER CLAMP NOT WORKING PROPERLY DURING TESTING. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6432726 ↗
• MalfunctionFeb 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00027).

  Patient problems: Not Applicable

  MAUDE report 6304813 ↗

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-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
• 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