Zyno B2-70070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10814371020140), received between Jul 6, 2017 and Sep 2, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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.

• MalfunctionSep 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED 105"ADMIN SET 20DP, PINCH CLAMP NON DEHP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THE ITEMS HAVE HOLES IN THEM AND BLOOD COMES OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415086 ↗
• MalfunctionAug 17, 2021Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00039).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331110 ↗
• MalfunctionJan 19, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Physical Property Issue; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Physical Property Issue

  THE INITIAL REPORTER REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET AT THE DRIP CHAMBER TO ZYNO MEDICAL ON (B)(6) 2018. A REGISTERED PHARMACY TECHNICIAN AT A USER FACILITY NOTIFIED A DISTRIBUTOR ON 12/19/2017 THAT "LAST WEEK WE HAD AN ISSUE WITH ONE OF THE TUBING LEAKING. I'M ALSO NOT SURE HOW THE GREEN CAP THAT GOES IN THE TUBING, WHERE THE CHEMO WAS LEAKING OUT OF, CAME OUT. I'VE ATTACHED SOME IMAGES FOR YOU TO SEE AS WELL AS A SHORT VIDEO CLIP." THE DISTRIBUTOR NOTIFIED THE INITIAL REPORTER ON 12/19/2017 THAT "I HAD EMAILED YOU ABOUT A MONTH AGO REGARDING ONCOLOGY CONSULTANTS HAVING AN ISSUE WITH THEIR TUBING LEAKING NEAR THE DRIP CHAMBER. I JUST RECEIVED THE EMAIL BELOW REGARDING ANOTHER TUBING SET LEAKING." THE DISTRIBUTOR ALSO STATED THAT "SINCE THE TUBING LEAKING INCIDENT INVOLVED THE MIXING AND COMPOUNDING OF CHEMO DRUGS THEY DISPOSED OF THE TUBING. THEY SAID IF IT HAPPENS IN THE FUTURE THEY WILL MAKE SURE TO SAFELY SECURE IT TO MAIL BACK." THE DISTRIBUTOR PROVIDED MORE INFORMATION ON (B)(6) 2018 THAT "SO FAR THREE PUMP SETS HAVE MALFUNCTIONED, 3 OF THE B2-70071-D AND 1 OF THE B2-70070. I WILL BE SENDING YOU ONE OF THE B2-70071-D. ALL SETS EXPERIENCED THE SAME ISSUE OF L

  Patient problems: No Patient Involvement

  MAUDE report 7207908 ↗
• MalfunctionNov 8, 2017Loose or Intermittent Connection; Connection Problem; Device Operates Differently Than Expected; Loose or Intermittent Connection; Connection Problem; Device Operates Differently Than Expected

  ZYNO MEDICAL RECEIVED A LETTER FROM FDA REGARDING A MEDWATCH VOLUNTARY REPORT (MW5072678) SUBMITTED ON 10/11/2017. THE USER REPORTED THAT "I RECEIVED REPORT FROM (8)(6) AT PATIENT'S DIALYSIS UNIT THAT AFTER STARTING THE IDPN THE INJECTION PORT ON THE ZYNO TUBING ADMINISTRATION SET CAME LOOSE AND BEGAN SHOOTING OUT BLOOD AT WHICH POINT THE PUMP WAS PROMPTLY STOPPED. THE INJECTION PORT WAS NEVER USED OR ACCESSED. THEY THEN OPENED A DIFFERENT PACKAGE AND IT WAS MISSING THE LUER LOCK CONNECTOR AT THE END OF THE TUBING, IT WAS JUST AN OPEN TUBE. THEY OPENED A THIRD PACKAGE AND IT WORKED TO ADMINISTER IDPN. ZYNO MEDICAL SET (8)(4). LOT 17035394, EXP 03/04/2020. TUBING SET WAS DISCARDED BY THE RN AT THE UNIT."

  Patient problems: Blood Loss

  MAUDE report 7009410 ↗
• MalfunctionJul 6, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Physical Property Issue; Fluid/Blood Leak; Device Operates Differently Than Expected; Physical Property Issue

  THE USER REPORTED AN IV SET LEAKING ISSUE. "WE SHIPPED OUR CUSTOMER 2 CASES OF YOUR ITEM # B2-70070. THERE IS AN INCONSISTENCY IN THE PRODUCT YOU ARE PROVIDING. IF YOU LOOK AT THE PHOTO ATTACHED YOU CAN SEE THAT THERE IS DIFFERENCE IN PACKAGING FOR THE SAME ITEM. THE ITEM ON THE LEFT IS OF POOR QUALITY AND IS LEAKING. THE ITEM IN THE CLEAR PACKAGING ON THE RIGHT IS SHOWING NO SIGNS OF QUALITY CONCERNS. YOU PROVIDED US WITH THE POOR QUALITY ITEM ON THE LEFT." THE TWO TYPES OF IV SETS ARE ACTUALLY MANUFACTURED BY TWO DIFFERENT CONTRACT SUPPLIERS OF ZYNO MEDICAL. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6690609 ↗

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-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-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