Zyno B2-70071-DF120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10814371020171), received between Jan 17, 2017 and Apr 14, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM AN END USER THAT "TUBING CONNECTED TO THE PATIENT, HEARD A LOUD POP DURING THE INFUSION AND IT WAS LEAKING FROM THE FILTER. CHECKED CLAMPS, AND NONE WERE ENGAGED. SWITCHED OUT TUBING, AND IT WORKED WITHOUT ISSUE ON THE NEXT TUBING." A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS REMICADE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115622 ↗
• MalfunctionDec 9, 2020Air/Gas in Device; Air/Gas in Device

  ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 10/24/2019, AND STATED THAT ADMINISTRATION SET MODEL#: B2-70071-DF LOT#: 1810012 FILTER DRAINS BACK, AND THEN WHEN THEY TURN THE PUMP ON THERE IS ABOUT 6 INCHES OF AIR. 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 PODO XINGDA (TIANJIN) MEDICAL CO., LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978832 ↗
• MalfunctionSep 25, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON 09/17/2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED AN ADMINISTRATION SET LEAKING ISSUE. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT AN ADMINISTRATION SET MODEL B2-70071-DF120, LOT NUMBER 16095885 LEAKED FROM THE 1.2-MICRON FILTER. THIS WAS ONE OF 3 OCCURRENCES AT A LONG TERM CARE FACILITY. SHE STATED THAT TYPICALLY WHEN IT OCCURRED THE RESIDENT HEARD IT POP AND THEN CALLED THE NURSE. SHE STATED THAT THEY WERE FOLLOWING PROTOCOL BY BEING SURE TO USE THE 1.2-MICRON FILTER. SHE ALSO STATED SHE WILL CONTACT THE FACILITY TO ASK IF THEY SAVED ANY OF THE SETS THAT LEAKED AND IF THEY COULD SEND A PHOTO OF ANY OF THEM. THE DISTRIBUTOR FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE FOR FURTHER INFORMATION, ADVISING THAT THEY NOT USE SETS ON THEIR EXPIRATION MONTH, AND DID NOT RECEIVE A RESPONSE. ON 09/23/2019, THE DISTRIBUTOR PROVIDED FURTHER INFORMATION ABOUT THE COMPLAINT. THE DISTRIBUTOR GOT A CALL FROM THE NUMBER (B)(6) FROM A PHARMACIST AT THE USER FACILITY, WHO STATED IT IS POSSIBLE THAT IN THIS CASE THE NURSES MIXED UP THE 1.2-MICRON FILTER WITH THE 0.2-MICRON FILTER SETS, DESPITE THEIR BEING DIFFERENT COLORS. THE PHARMACIST WANTED TO BE SURE THERE HAD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9115706 ↗
• MalfunctionSep 25, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON (B)(6) 2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED AN ADMINISTRATION SET LEAKING ISSUE. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT AN ADMINISTRATION SET MODEL B2-70071-DF120 LOT NUMBER 16095885 LEAKED FROM THE 1.2-MICRON FILTER. THIS WAS ONE OF 3 OCCURRENCES AT A LONG TERM CARE FACILITY. SHE STATED THAT TYPICALLY WHEN IT OCCURRED THE RESIDENT HEARD IT POP AND THEN CALLED THE NURSE. SHE STATED THAT THEY WERE FOLLOWING PROTOCOL BY BEING SURE TO USE THE 1.2-MICRON FILTER. SHE ALSO STATED SHE WILL CONTACT THE FACILITY TO ASK IF THEY SAVED ANY OF THE SETS THAT LEAKED AND IF THEY COULD SEND A PHOTO OF ANY OF THEM. THE DISTRIBUTOR FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE FOR FURTHER INFORMATION, ADVISING THAT THEY NOT USE SETS ON THEIR EXPIRATION MONTH, AND DID NOT RECEIVE A RESPONSE. ON (B)(6) 2019, THE DISTRIBUTOR PROVIDED FURTHER INFORMATION ABOUT THE COMPLAINT. THE DISTRIBUTOR GOT A CALL FROM THE NUMBER (B)(6) FROM A PHARMACIST AT THE USER FACILITY, WHO STATED IT IS POSSIBLE THAT IN THIS CASE THE NURSES MIXED UP THE 1.2-MICRON FILTER WITH THE 0.2-MICRON FILTER SETS, DESPITE THEIR BEING DIFFERENT COLORS. THE PHARMACIST WANTED TO BE SURE THERE HAD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9115704 ↗
• MalfunctionSep 25, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON (B)(6) 2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED AN ADMINISTRATION SET LEAKING ISSUE. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT AN ADMINISTRATION SET MODEL B2-70071-DF120, LOT NUMBER 16095885 LEAKED FROM THE 1.2-MICRON FILTER. THIS WAS ONE OF 3 OCCURRENCES AT A LONG TERM CARE FACILITY. SHE STATED THAT TYPICALLY WHEN IT OCCURRED THE RESIDENT HEARD IT POP AND THEN CALLED THE NURSE. SHE STATED THAT THEY WERE FOLLOWING PROTOCOL BY BEING SURE TO USE THE 1.2-MICRON FILTER. SHE ALSO STATED SHE WILL CONTACT THE FACILITY TO ASK IF THEY SAVED ANY OF THE SETS THAT LEAKED AND IF THEY COULD SEND A PHOTO OF ANY OF THEM. THE DISTRIBUTOR FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE FOR FURTHER INFORMATION, ADVISING THAT THEY NOT USE SETS ON THEIR EXPIRATION MONTH, AND DID NOT RECEIVE A RESPONSE. ON (B)(6) 2019, THE DISTRIBUTOR PROVIDED FURTHER INFORMATION ABOUT THE COMPLAINT. THE DISTRIBUTOR GOT A CALL FROM THE NUMBER (B)(6) FROM A PHARMACIST AT THE USER FACILITY, WHO STATED IT IS POSSIBLE THAT IN THIS CASE THE NURSES MIXED UP THE 1.2-MICRON FILTER WITH THE 0.2-MICRON FILTER SETS, DESPITE THEIR BEING DIFFERENT COLORS. THE PHARMACIST WANTED TO BE SURE THERE HA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9115701 ↗
• MalfunctionFeb 7, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  THE INITIAL REPORTER REPORTED AN IV SET LEAKING ISSUE AT THE FILTER TO ZYNO MEDICAL ON 01/29/2018: "DURING MY VISIT AT (B)(6) ON (B)(6) 2018, THERE WERE STILL INCIDENTS OF LEAKING AT THE FILTER PORTION OF THE TPN TUBINGS ACCORDING TO (B)(6), RN SUPERVISOR (B)(6) AND ALSO WITNESSED BY THE RESIDENT. I ASKED THE RN SUPERVISORS TO SEND THESE DEFECTIVE TUBINGS TO PHARMACY FOR INVESTIGATION. THE FACILITY HAS IV TUBINGS B2-70071-DF120; LOT # 16095886; EXP DATE 09/2019. I AM STILL WAITING FOR THE RESULT/FINDINGS OF THE DEFECTIVE TUBING I SENT ON DECEMBER 4, 2017." ZYNO MEDICAL WAS ABLE TO OBTAIN RESPONSES FROM THE RN AT THE USER FACILITY ON 01/31/2018: "TUBINGS AVAILABLE IN THE FACILITY ON (B)(6) 2018: B2-70071-DF120, LOT # 16095886. PER RN SUPERVISORS' AND PATIENT'S ACCOUNTS, THE LEAKING HAPPENED SEVERAL TIMES AND WERE NOTICED AT THE FILTER CASING. NO INJURIES DOCUMENTED. TPN SOLUTION WAS INFUSING AT 92 ML/HR. THE INCIDENTS HAPPENED BETWEEN 2ND AND 3RD WEEK OF (B)(6) 2018 AT (B)(6). THE INCIDENTS WERE JUST VERBALLY REPORTED BY THE FACILITY NURSES ON (B)(6) 2018. UNFORTUNATELY THE TUBINGS WERE NOT COLLECTED. I ASKED THE NURSES TO COLLECT DEFECTIVE TUBINGS FOR INVESTIGATION. " NO SPECIFIC E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247349 ↗
• MalfunctionJan 19, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A DISTRIBUTOR REPORTED A LEAKING ISSUE TO ZYNO MEDICAL ON 01/11/2018. THE FOLLOWING INFORMATION WAS FORWARDED FROM THE USER FACILITY TO THE DISTRIBUTOR ON 01/11/2018: "THE PATIENT WAS ADMITTED ON (B)(6) 2018 SO I AM ASSUMING THE TUBING WAS DELIVERED AT THE SAME TIME. THE PROBLEM IS THE TUBING WAS LEAKING AT THE FILTER. THE TUBING WAS CHANGED 3 TIMES. I ONLY HAVE 1 LEFT OF THE ORIGINAL TUBING, THE REST WAS THROWN AWAY YESTERDAY WHEN WE RECEIVED A NEW BATCH. THERE ARE A COUPLE NUMBERS ON THE PACKAGE WITH EXPIRATION OF 09/2019. THIS PROBLEM HAS BEEN REPORTED TO THE TUBING COMPANY. THEY CONDUCTED THEIR OWN TESTS AND FOUND ZERO TUBING THAT LEAKED." ZYNO MEDICAL FOLLOWED UP WITH THE REPRESENTATIVE AT THE USER FACILITY ON 01/11/2018 AND OBTAINED THE RESPONSE: "THERE WAS NO INJURY TO THE PATIENT, THE IV TUBING WAS LEAKING NEAR THE FILTER ON A COUPLE OF THE TUBING'S IN THIS BATCH. I BELIEVE IT HAPPENED ON A COUPLE DIFFERENT DAYS. YES, I HAVE ONE SET I WAS ABLE TO GRAB". NO PATIENT INJURY OCCURED FOR THIS EVENT. THE EVENT DATE WAS REPORTED AS (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207886 ↗
• MalfunctionDec 7, 2017Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00319).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7097059 ↗
• MalfunctionSep 12, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED A LEAKING ISSUE WITH ADMINISTRATION SETS. "IT IS LEAKING OUT OF THE CONNECTION AT THE FILTER COMPONENT IN ABOUT FIVE SETS." THE CUSTOMER ALSO REPORTED OVER THE PHONE THAT THE ISSUE HAD BEEN HAPPENING IN THE PAST, BUT THE MOST RECENT CASE WAS ON (B)(6) 2017 WHILE THEY WERE PRIMING THE TUBING. THE IV SET WAS LEAKING BELOW THE FILTER IN WHICH IT CONNECTED WITH THE TUBING ITSELF. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT FOR THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6857575 ↗
• MalfunctionJun 28, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00223).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6674989 ↗
• MalfunctionMay 18, 2017Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00121).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577114 ↗
• MalfunctionJan 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00013).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6258244 ↗

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-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