Zyno B2-70071-DFRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10814371020164), received between Jan 6, 2017 and Nov 19, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  INTUVIE RECEIVED A REPORT INDICATING THAT RIGHT WAY MEDICAL RECEIVED A COMPLAINT STATING, ¿THE FILTER TUBING I USED TODAY HAD A CRACK IN IT, WHICH EVENTUALLY CAUSED SOME MEDICATION TO SPRAY OUT.¿ THE PACKAGING WAS REPORTED TO BE INTACT WHEN THE NURSE OPENED THE TUBING SET. THE FILTER BEGAN LEAKING APPROXIMATELY TWO HOURS INTO THE INFUSION. GAMMAGARD S-D WAS BEING INFUSED AT THE TIME OF THE EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597336 ↗
• MalfunctionJan 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR AND STATED THAT AN ADMINISTRATION SET MODEL B2-70071-DF, LOT 22065862 "HAS HAD MULTIPLE PROBLEMS WITH THE FILTER LEAKING AND SPILLING DRUGS FROM THE TUBING." A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS UNKNOWN. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16178944 ↗
• MalfunctionDec 14, 2022Leak/Splash; Leak/Splash

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT THAT "AN ADMINISTRATION SET MODEL B2-70071-DF LOT 22055801 POPED AT THE FILTER RIGHT AWAY WHEN A CHEMO INFUSION STARTED. NO MEDICATION INFUSED SINCE THE FILTER BROKE RIGHT AT THE START OF THE INFUSION." THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS UNKNOWN. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980445 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM AN END USER REGARDING A LEAKING ISSUE. IT WAS REPORTED THAT "THE LEAK WAS COMING FROM BELOW THE BOTTOM FILTER ON THE TUBING, AND IT WOULD HAPPEN IMMEDIATELY." THE END USER ALSO STATED THAT "THIS EVENT TOOK PLACE 4 TIMES IN A SINGLE DAY ALL ON (B)(6) 2022". THE DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS REMICADE. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014031 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM AN END USER REGARDING A LEAKING ISSUE. IT WAS REPORTED THAT "THE LEAK WAS COMING FROM BELOW THE BOTTOM FILTER ON THE TUBING, AND IT WOULD HAPPEN IMMEDIATELY." THE END USER ALSO STATED THAT "THIS EVENT TOOK PLACE 4 TIMES IN A SINGLE DAY ALL ON (B)(6) 2022". THE DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS REMICADE. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014030 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6)2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM AN END USER REGARDING A LEAKING ISSUE. IT WAS REPORTED THAT "THE LEAK WAS COMING FROM BELOW THE BOTTOM FILTER ON THE TUBING, AND IT WOULD HAPPEN IMMEDIATELY." THE END USER ALSO STATED THAT "THIS EVENT TOOK PLACE 4 TIMES IN A SINGLE DAY ALL ON (B)(6)2022". THE DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS REMICADE. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014029 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM AN END USER REGARDING A LEAKING ISSUE. IT WAS REPORTED THAT "THE LEAK WAS COMING FROM BELOW THE BOTTOM FILTER ON THE TUBING, AND IT WOULD HAPPEN IMMEDIATELY." THE END USER ALSO STATED THAT "THIS EVENT TOOK PLACE 4 TIMES IN A SINGLE DAY ALL ON (B)(6) 2022". THE DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS REMICADE. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014028 ↗
• MalfunctionMay 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ADMIN SET 20DP W/ FILTER Y SITE CLMP HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70071-DF. BATCH NO: 21015465. IT WAS REPORTED THE SET HAD LOOSE PIECES OF THE SPIKE ON THE SIDE ONCE IT WAS SPIKED INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891443 ↗
• MalfunctionMay 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT 2 ADMIN SET 20DP W/ FILTER Y SITE CLMP WERE NOT STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70071-DF. BATCH NO: 21045386, 21045387. THE PRODUCTS DID NOT MEET THE STERILIZATION SPECIFICATION. THE CERTIFICATE OF PROCESSING WAS APPROVED WITHOUT NOTICING THE ISSUE. IT IS NOT A TYPO ERROR IN THE PAPERWORK. THE CERTIFICATE OF PROCESSING INDICATED THAT THE VESSEL PROCESSING TIME OF ETO STERILIZATION WAS OUT OF SPECIFICATION. I WOULD THINK IT IS A STERILIZATION FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882887 ↗
• MalfunctionMay 5, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00025).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776834 ↗
• MalfunctionApr 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 ADMIN SETS 20DP W/ FILTER Y SITE CLMP LEAKED AT THE FILTER DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2021 A USER REPORTED THAT AN ADMINISTRATION SET MODEL B2-70071-DF LOT 20085018 WAS LEAKING AT THE FILTER CLOSEST TO THE PATIENT. IT HAPPENED ON TWO SEPARATE OCCASIONS. OPERATOR RN. MEDICATION ENTYVIO. PATIENT INVOLVED. PATIENT NOT HARMED. USER IS UNSURE OF THE EXACT DATE. HAPPENED OVER THE LAST COUPLE OF WEEKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729537 ↗
• MalfunctionMar 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 ADMIN SETS 20DP W/ FILTER Y SITE CLMP LEAKED FROM THE FILTER NEAR THE PATIENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2021 A USER REPORTED THAT AN ADMINISTRATION SET MODEL B2-70071-DF, LOT 20085018 WAS LEAKING AT THE FILTER CLOSEST TO THE PATIENT. IT HAPPENED ON TWO SEPARATE OCCASIONS (SECOND SEPARATE COMPLAINT WILL BE SENT). OPERATOR RN. MEDICATION ENTYVIO. PATIENT INVOLVED. PATIENT NOT HARMED. USER IS UNSURE OF THE EXACT DATE. HAPPENED OVER THE LAST COUPLE OF WEEKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548124 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00014).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463946 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00015).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463907 ↗
• MalfunctionNov 21, 2019Improper Chemical Reaction; Manufacturing, Packaging or Shipping Problem; Component Misassembled; Improper Chemical Reaction; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  A DISTRIBUTOR REPORTED AN ISSUE OF ADMINISTRATION SETS TO ZYNO MEDICAL ON 11/06/2019: "ON (B)(6) 2019, (B)(4) OF ZYNO SOLUTIONS RECEIVED A EMAIL FROM (B)(6). (B)(6) STATED THAT AN ADMINISTRATION SET MODEL#: B2-70071-DF; LOT#: 19066538, PATIENTS WERE HAVING STRANGE REACTIONS TO CHEMOS THAT THEY WERE PREVIOUSLY FINE WITH. KASEE STATED THIS HAPPENED FOR ROUGHLY 25-30 INFUSIONS. THEY STARTED ADDING A BAXTER FILTER TO THE END OF THE ZYNO TUBING AND THIS ISSUE STOPPED. OPERATOR RN. MEDICATION TAXOL OR OPDIVO. 8 PATIENTS INVOLVED. 8 PATIENTS WERE HARMED, EMERGENCY MEDICINE HAD TO BE ADMINISTERED TO ALL 8 PATIENTS ON MULTIPLE OCCASIONS. (B)(6) STATED THAT ONCE A PATIENT HAD AN ANAPHYLACTIC REACTION AND THEY HAD TO USE EPI TO GET HER AIRWAY REGULATED. (B)(6) 2019." THE DISTRIBUTOR PROVIDED AN UPDATE OF THE ISSUE ON 11/07/2019: "PROBLEMS BEGAN IN (B)(6) WITH PATIENT'S HAVING REACTIONS TO TAXOL INFUSIONS AND 1 PATIENT HAD A REACTION TO OPDIVO (BOTH INFUSIONS REQUIRE A FILTER). ONCE THE REACTIONS KEPT HAPPENING, THEY TOOK A FURTHER LOOK AT THEIR PRACTICE TO SEE IF MAYBE THE PRE-MEDS HAD BEEN GIVEN DIFFERENT. AFTER RE-ANALYZING THEIR PRE-MED ADMINISTRATION AND SEEING THAT IT WAS THE SAME PROCES

  Patient problems: Hypersensitivity/Allergic reaction; Patient Problem/Medical Problem

  MAUDE report 9359118 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3006575795-2019-00015.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8750214 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00019).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8750213 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00018).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8750211 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00017).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8750210 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00016).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8750208 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  ZYNO MEDICAL RECEIVED A NEEDLESS INJECTION SITE LEAKING ISSUE FROM A DISTRIBUTOR REPRESENTATIVE ON 04/23/2019. THE DISTRIBUTOR REPRESENTATIVE FORWARDED AN EMAIL ON (B)(6) 2019 FROM THE USER FACILITY, WHICH INDICATED THAT THE USER "HAD TWO TUBING FAILURES TODAY OF ZYNO TUBING AND THAT THE DRUGS HAD TO BE WASTED". IT WAS ALSO REPORTED THAT "THE LEAKS OCCURED WHERE THE NEEDLELESS INJECTION PORT ENTERS THE IV TUBING. SHE MENTIONED THE SET HAD A FILTER AND WAS 105" LONG. SHE SAVED ONE OF THE TUBING AND MEDICATION SETS, WHILE THE OTHER WAS DISCARDED DUE TO HAVING A LOT OF THE PATIENT'S BLOOD THAT LEAKED AND BACKED UP IN THE TUBING". ON (B)(6) 2019, THE DISTRIBUTOR REPORTED MORE INFORMATION OBTAINED FROM THE USER FACILITY: "AFTER WE HAD THOSE 2 TUBING FAILURES WE SWITCHED TO TUBING WITH DIFFERENT LOT NUMBERS. WE NOW HAVE APPROX. 7 BOXES WITH THE LOT # THAT LEAKED. I TRIED TO REPLICATE IT AGAIN WITH ANOTHER SET AND WAS UNABLE TO. I WILL SEND YOU THE TUBING WITH THE SIMPONI ARIA BAG ATTACHED. LET ME KNOW IF YOU NEED ANYTHING ELSE. I DON'T KNOW IF THIS WAS RANDOM OR A PROBLEM WITH THIS LOT. "THE MEDICATION INFUSED AT THE TIME OF THE EVENT WAS RITUXAN. NO SECONDARY SET WAS USED AT THE TIME OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579642 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THIS IS A FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3006575795-2019-00010).

  Patient problems: No Patient Involvement

  MAUDE report 8579636 ↗
• MalfunctionMay 24, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  DURING A VISIT TO THE USER FACILITY, A DISTRIBUTOR REPRESENTATIVE DISCOVERED A LEAKING ISSUE WITH THE TUBING WHILE IT WAS ATTACHED TO THE PATIENT AND REPORTED IT TO ZYNO MEDICAL ON (B)(6) 2018. THE LEAKING WAS REPORTED TO OCCUR "MIDDLE OF THE LINE". NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE. THE EVENT DATE WAS (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542012 ↗
• MalfunctionApr 18, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  ZYNO MEDICAL WAS NOTIFIED OF A FILTER LEAKING ISSUE ON (B)(6) 2018: "I PICKED UP A ADMIN. SET (B)(4). THE (B)(6) 2018 PRODUCT FAILURE AT THE FILTER, LEAKING. PUMP USED (B)(4). CUSTOMER NOTICED LEAK DURING INFUSION. WAS ABLE TO STOP THE INFUSION AND USE A NEW ADMIN SET AND CONTINUE WITH THE THERAPY. I HAVE SET AND LOT#17067246". THROUGH THE FOLLOW-UP WITH THE INITIAL REPORTER, IT WAS CONFIRMED THAT NO PATIENT INJURY OCCURED IN THIS CASE AND THE EVENT DATE WAS (B)(6) 2018. THE INITIAL REPORTER ALSO CONFIRMED THAT THE LEAKING ISSUE WAS FOUND DURING INFUSION ON THE FILTER HOUSING. ON (B)(6) 2018, THE INITIAL REPORTER PROVIDED MORE INFORMATION ON THE MEDICATION USED: " THE PUMP WAS INFUSING OCREVUS 600MG/500ML NACL, ABOUT 30 MIN IN TO A 5HR, INFUSION THE RATE AT THAT TIME WAS 80ML/HR. AT THE TIME THE LEAK WAS NOTICED THE PUMP WAS BEING RESTARTED AFTER A BATHROOM BREAK. WE HAD AN OCCLUSION ALARM AND THE NURSE WAS USING THE PRIME BUTTON WHEN NOTICED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441199 ↗
• MalfunctionSep 5, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00263).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6842330 ↗

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-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-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-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