Zyno B2-70072Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10814371020195), received between Dec 30, 2016 and Jul 2, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (23 reports).

1 FDA recall record name this device's identifier.

5 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.

Recalls naming this device

1. May 29, 2019Terminated

   Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

   Z-2058-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Loss of or Failure to Bond

  THE REPORTER ALLEGED THAT AN IV ADMINISTRATION SET EXPERIENCED TUBING SEPARATION FROM THE MALE LUER LOCK ADAPTOR PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692802 ↗
• MalfunctionDec 23, 2025Backflow; Backflow

  IT WAS REPORTED TO INTUVIE THAT THE BACK CHECK VALVE FAILED, CAUSING CHEMOTHERAPY AND OTHER MEDICATIONS ON A SECONDARY SET TO FLOW BACK INTO THE PRIMARY LINE. ON NOVEMBER 25, 2025, THE CUSTOMER PROVIDED FOLLOW-UP INFORMATION STATING: ¿WE ACTUALLY HAD ONE DO IT TODAY WHILE INFUSING TAXOL. UNFORTUNATELY, WE ARE NOT SURE WHICH LOT NUMBER OF THE TWO WE USED TODAY. THE TWO POSSIBLE LOT NUMBERS ARE (B)(4) 25045349 AND (B)(4) 25045698. I DO NOT HAVE A PICTURE OF THE SETUP SINCE IT CONTAINED PATIENT INFORMATION¿. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881318 ↗
• MalfunctionDec 12, 2025Backflow; Backflow

  ON NOVEMBER 14, 2025, INTUVIE RECEIVED A REPORT FROM A CUSTOMER STATING THAT THEY WERE EXPERIENCING ISSUES WITH B2-70072 TUBING, SPECIFICALLY THAT THE BACK CHECK VALVE WAS FAILING, RESULTING IN CHEMOTHERAPY AND OTHER MEDICATIONS FROM A SECONDARY SET FLOWING BACK INTO THE PRIMARY LINE. THE CUSTOMER REPORTED THAT THIS ISSUE HAD OCCURRED AT LEAST 30 TIMES, AND POSSIBLY MORE, AND DESCRIBED IT AS A SIGNIFICANT CONCERN. THE EVENTS WERE REPORTED TO OCCUR AT VARIOUS POINTS DURING THERAPY, INCLUDING IMMEDIATELY AFTER CONNECTING THE SECONDARY SET AND DURING THE COURSE OF TREATMENT. THE CUSTOMER INDICATED THAT THE ISSUE WAS NOT LIMITED TO A SINGLE BOX OF TUBING BUT HAD BEEN OBSERVED ACROSS MULTIPLE BOXES OVER THE PAST SEVERAL MONTHS. NO PATIENT HARM WAS REPORTED. ON NOVEMBER 21, 2025, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE CUSTOMER, WHO REPORTED MULTIPLE INCIDENTS IN WHICH THE SECONDARY INFUSION FLOWED INTO THE PRIMARY FLUID BAG. THE CUSTOMER EXPLAINED THAT THE B2-70072 TUBING SET WAS LOADED INTO THE PUMP WITH THE PRIMARY BAG HANGING ON THE POLE, AND WHEN THE SECONDARY LINE WAS CONNECTED ABOVE THE PUMP AND LOWERED TO BACK-PRIME THE LINE, THEN REHUNG ABOVE THE PRIMARY BAG, FLUID FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795304 ↗
• MalfunctionNov 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # B2-70072. BATCH # 23115265. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND FOREIGN MATERIAL ON THE ADMINISTRATION SET. RCC RECEIVED A COMPLAINT VIA EMAIL. FOREIGN MATERIAL FOUND ON ADMINISTRATION SETS. PRODUCT#: B2-70072. LOT#: 23115265.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708269 ↗
• MalfunctionAug 9, 2023Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  AS SOON AS THE TUBING WAS CONNECTED, BLOOD BEGAN FLOWING BACK UP INTO THE LINE. FLUID THEN BEGAN LEAKING FROM THE INJECTION SITE. MEDICATION WAS UNKNOWN. VOLUME TO BE INFUSED WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17487964 ↗
• MalfunctionJul 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED "SMALL HOLE IN THE CHAMBER AND CAUSED IMMEDIATE LEAKING". MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270443 ↗
• MalfunctionMay 2, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  SALES ASSOCIATE REPORTED "CUSTOMER JUST OPENED UP A MOLDY Z-800F SET". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852095 ↗
• MalfunctionDec 21, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  ON 12/06/2021, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE THAT "AN ADMINISTRATION SET MODEL B2-70072 LOT 20115703 WOULD ONLY STOP FLOWING IF ALL THREE CLAMPS WERE ENGAGED." 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 13053913 ↗
• MalfunctionJul 8, 2021Backflow; Backflow

  IT WAS REPORTED THAT 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD BACKFLOW. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY SET WAS BACKFLOWING INTO THE SECONDARY SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140145 ↗
• MalfunctionMay 26, 2021Backflow; Backflow

  IT WAS REPORTED THAT 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD BLOOD BACKFLOW. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072, BATCH NO: 20085276. IT WAS REPORTED THE SECONDARY SET BACKED UP INTO THE PRIMARY SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891519 ↗
• MalfunctionFeb 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072 BATCH NO: 20066195 IT WAS REPORTED THAT THE ADMINISTRATION SET WAS DIRTY ON THE INSIDE OF THE DRIP CHAMBER. VERBATIM: ON (B)(6) 2021 A USER REPORTED AN ISSUE WITH THE B2-70072 ADMINISTRATION SET WHERE THE USER STATED ¿ADMINISTRATION SET WAS DIRTY ON THE INSIDE OF THE DRIP CHAMBER. WAS NOTICED AFTER AN INFUSION. OPERATOR RN. MEDICATION VIDAZA. PATIENT INVOLVED. PATIENT WAS NOT HARMED." SET WAS SENT TO DISTRIBUTOR ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11380631 ↗
• MalfunctionFeb 10, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00003).

  Patient problems: Fever

  MAUDE report 11307455 ↗
• MalfunctionDec 2, 2020Component Misassembled; Component Misassembled

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00040).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931499 ↗
• MalfunctionJul 7, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT 105 ADMIN SET 20DP, W/2 Y SITE, CV CLMPS HAD BACK FLOW ISSUES. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072, BATCH (LOT) NO: 19105051. IT WAS REPORTED THAT ADMINISTRATION SETS HAD BACK FLOW ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10242928 ↗
• MalfunctionMay 16, 2019Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  ZYNO MEDICAL RECEIVED AN INVERTED PINCH CLAMP ISSUE FROM A DISTRIBUTOR REPRESENTATIVE ON 04/30/2019. THE INITIAL REPORTER FROM USER FACILITY REPORTED TO THE DISTRIBUTOR ON (B)(6) 2019 THAT "THERE HAD BEEN SEVERAL INSTANCES WHERE ADMINISTRATION SETS MODEL B2-70072 HAD PINCH CLAMPS THAT WERE UPSIDE DOWN". THE DISTRIBUTOR ALSO REPORTED THAT USER FACILITY REPRESENTATIVE "HAD SAVED ONE AND SAID HE WOULD SEND IT TO US FOR AN EVALUATION". THE DISTRIBUTOR ALSO REPORTED THAT THE "B2-70072 SETS AT HIS FACILITY WERE ALL FROM EITHER OF TWO LOT NUMBERS: 18037128 (OF WHICH THEY WERE SENT 3 BOXES ON (B)(6) 2019) OR 18065375 (OF WHICH THEY WERE SENT 4 BOXES ON (B)(6) 2019)". NO PATIENT WAS INVOLVED IN THIS EVENT. NO MEDICATION WAS BEING INFUSED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Patient Involvement

  MAUDE report 8617625 ↗
• MalfunctionMay 3, 2019Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00005).

  Patient problems: No Patient Involvement

  MAUDE report 8579635 ↗
• MalfunctionDec 7, 2017Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  THE USER REPORTED A FOREIGN OBJECT ISSUE OF THE DEVICE ON (B)(6) 2017. "WE HAD AN INCIDENT TODAY INVOLVING AN ADMINISTRATION SET THAT CONTAINED A CONTAMINANT. THIS WAS A PRIMARY TUBING SET (B2-70072) THAT WAS USED AND SEVERAL MEDICATIONS WERE Y-SITED INTO IT BEFORE THE CONTAMINANT WAS NOTICED. WE HAVE KEPT THE TUBING AND HAVE INCLUDED A PICTURE. IT APPEARS TO BE WEDGED BETWEEN THE TUBING/PORT CONNECTION." NO PATIENT INJURY OCCURRED FOR THIS CASE. THE MEDICATIONS USED DURING THIS INFUSION WERE SODIUM CHLORIDE, RITUXIMAB, VINCRISTINE, DOXORUBICIN, EMEND, ALOXI, AND BENADRYL. THE EVENT DATE WAS REPORTED AS (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7097072 ↗
• MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ZYNO MEDICAL RECEIVED THE DEVICE FROM THE USER ON (B)(6) 2017. THE CUSTOMER SERVICE REPRESENTATIVE AT ZYNO MEDICAL CONTACTED THE USER ON (B)(6) 2017 AND THE USER REPORTED THAT THIS DEVICE WAS THE AFFECTED DEVICE FROM MDR 3006575795-2017-00268_COMPLAINT (B)(4). ZYNO MEDICAL COMMUNICATED WITH THE USER STATING THAT THE DEVICE RECEIVED WAS A USED PRIMARY ADMINISTRATION SET. THIS PRIMARY SET WAS CONNECTED TO A 5% DEXTROSE SOLUTION BAG WHILE ALSO ATTACHED TO A SECONDARY ADMINISTRATION SET WITH A SOLUTION OF 0.9% SODIUM CHLORIDE WITH DIPHENHYDRAMINE. NEITHER OF THE RECEIVED ADMINISTRATION SETS MATCHES THE DESCRIPTION OF THE AFFECTED DEVICE IN COMPLAINT (B)(4). ZYNO MEDICAL IS STILL IN THE PROCESS OF CONTACTING THE CUSTOMER REGARDING THE COMPLAINT NATURE OF THE RECEIVED DEVICE. NO PATIENT INJURY OR HARM WAS REPORTED AND NO EVENT DATE WAS PROVIDED BY THE USER.

  Patient problems: No Information

  MAUDE report 6996353 ↗
• MalfunctionOct 30, 2017Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected; Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected

  THE USER REPORTED A LEAKING ISSUE WITH THE ADMINISTRATION SET TO INFUTRONIX ON (B)(6) 2017." 1 NIMBUS FLEX II ADMINISTRATION SET-IT1032 WITH CHECK VALVE LEAKED ABOUT 20 CC'S 5FU FORM WHAT APPEARED TO BE THE AIR ELIMINATING 1.2 MICRON FILTER. THE RN NOTICED THIS AND THE SET WAS PROVIDED TO PHARMACY THAT SAVED THE SET AND WILL RETURN FOR ROOT CAUSE." NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6986544 ↗
• MalfunctionJun 15, 2017Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected; Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00230).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645309 ↗
• MalfunctionMay 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00130).

  Patient problems: Not Applicable

  MAUDE report 6587646 ↗
• MalfunctionMay 11, 2017Leak/Splash; Device Operates Differently Than Expected; Free or Unrestricted Flow; Leak/Splash; Device Operates Differently Than Expected; Free or Unrestricted Flow

  THE USER REPORTED THAT AN IV SET LEAKING ISSUE. "MOST OF THE OFFICES ONLY EXPERIENCED LEAKING FROM THE UPPER Y SITE AND BACK CHECK VALVE ISSUES. THERE WERE NO PATIENT INJURIES BUT THE LEAKS DID CAUSE CHEMO SPILLS. THOSE SETS WERE IMMEDIATELY DESTROYED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6560038 ↗
• MalfunctionMay 10, 2017Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY-FILED MDR (3006575795-2017-00106).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6556916 ↗
• MalfunctionMar 4, 2017Detachment Of Device Component; Detachment Of Device Component

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00061).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6379081 ↗
• MalfunctionMar 4, 2017Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE USER REPORTED LEAKAGE OF AN IV SET FROM THE BASE OF THE DRIP CHAMBER. NO PATIENT HARM OR INJURY WAS INVOLVED IN THIS COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6379075 ↗

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-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