Zyno B2-70071-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10814371020157), received between Jan 12, 2017 and Apr 29, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Leak/Splash

  A CUSTOMER REPORTED THAT A BATCH OF IV TUBING IN USE WAS FAULTY AND LEAKING DURING INFUSION. THE REPORTER INDICATED THAT AFTER SWITCHING TO A NEW BATCH OF TUBING, THE ISSUE WAS NO LONGER OBSERVED AND SUBSEQUENT INFUSIONS WERE COMPLETED SUCCESSFULLY. NO ADVERSE EVENT OR PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032420 ↗
• MalfunctionFeb 8, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288683 ↗
• MalfunctionFeb 8, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288682 ↗
• MalfunctionJun 17, 2024Contamination; Contamination

  05/28/2024, INFUTRONIX MEDICAL RECEIVED A REPORT FROM THE CUSTOMER THAT ONE OF THE CASES/POUCH HAD BEEN PHYSICALLY DAMAGED B2-70071-D. NO REPORT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553164 ↗
• MalfunctionAug 25, 2022Break; Leak/Splash; Break; Leak/Splash

  ON (B)(6) 2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE. IT WAS REPORTED THAT "WE HAD AN INCIDENT HAPPEN WHERE THE TUBING COMPLETELY BROKE OFF AT THE HUB. LUCKILY, THE PATIENT NOTICED QUICKLY AND NOT MUCH DRUG WAS LEAKED." 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 15294975 ↗
• MalfunctionDec 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE 105" ADMIN SET 20DP, W/Y SITE CLAMPS TUBING WAS FOUND "CRIMPED" BELOW THE DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN ADMINISTRATION SET MODEL B2-70071-D LOT 20025258 SET WAS CRIMPED BELOW THE DRIP CHAMBER. OPERATOR PHARMACY TECHNICIAN. MEDICATION NORMAL SALINE. NO PATIENT INVOLVED. PATIENT WAS NOT HARMED. (B)(6) 2020." "PERFORMED A VISUAL INSPECTION, AND IT WAS CONFIRMED THAT THE TUBING WAS CRIMPED BELOW THE DRIP CHAMBER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10939368 ↗
• MalfunctionOct 5, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON 09/26/2018. THE DISTRIBUTOR RECEIVED A CALL FROM THE INITIAL REPORTER ON (B)(6) 2018, STATING THAT THE ADMINISTRATION SET TUBING WAS LEAKING BELOW THE DRIP CHAMBER. THE AFFECTED ADMINISTRATION SET WAS INFUSING CHEMO. THERE WAS NO PATIENT INJURY AND NO PATIENT INFORMATION WAS PROVIDED TO ZYNO MEDICAL. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940058 ↗
• MalfunctionSep 28, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2018. THE DISTRIBUTOR RECEIVED A CALL FROM THE INITIAL REPORTER, STATING THAT THE ADMINISTRATION SET TUBING WAS LEAKING BELOW THE DRIP CHAMBER. THE AFFECTED ADMINISTRATION SET WAS INFUSING SALINE. THERE WAS NO PATIENT INJURY AND NO PATIENT INFORMATION WAS PROVIDED TO ZYNO MEDICAL. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918806 ↗
• MalfunctionJun 14, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON 05/25/2018: " I HOPE THIS FINDS YOU WELL! ONCOLOGY CONSULTANTS HAS HAD ANOTHER ISSUE WITH A SET (B2-70071-D) LEAKING. IF YOU ALL COULD PLEASE FURTHER INVESTIGATE THIS BY REACHING OUT TO THE MANUFACTURER OR SOMETHING IT WOULD BE MUCH APPRECIATED. THE AMOUNT OF SETS THAT THEY HAVE HAD ISSUES WITH IS A LITTLE EXCESSIVE. I HAVE PROVIDED ANSWERS TO THE USUAL QUESTIONS BELOW, ALONG WITH THE ADDRESS OF WHERE TO SHIP THE REPLACEMENT SET. ALSO, THE TUBING DID NOT HAVE CHEMO IN IT. I HAVE ALREADY SHIPPED THE SET TO YOU AS WELL. IF YOU HAVE ANY FURTHER QUESTIONS PLEASE LET ME KNOW. WAS A PATIENT INVOLVED(CONNECTED TO PUMP) WHEN ISSUE WAS NOTICED? PATIENT WAS CONNECTED TO PUMP. IF SO, WERE THERE ANY INJURIES? NO. DO YOU KNOW THE DATE THIS ISSUE WAS FIRST NOTICED? (B)(6) 2018. DO YOU KNOW IF THE NURSE WAS PRIMING THE TUBING EVEN THOUGH THE PUMP WAS ALARMING OCCLUSION? THERE WAS NO PRIMING, THE PUMP NEVER SHOWED OCCLUSION, RN NOTICED THE TUBING WAS LEAKING AND DAMP. DO YOU HAVE THE 7 OR 8 DIGIT LOT NUMBER OF THE IV SET THAT EXPERIENCED THIS ISSUE(IT SHOULD BE ON THE PACKAGING SOMEWHERE AND THIS TELLS ME WHO THE MA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602684 ↗
• MalfunctionJun 14, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2018: "THE NURSE WAS IN THE PROCESS OF SETTING UP THE INFUSION, BUT BEFORE IT WAS CONNECTED TO THE PATIENT SHE HAD NOTICED THE LEAK." THE DISTRIBUTOR MENTIONED THAT THE LEAKING OCCURRED JUST BELOW THE DRIP CHAMBER. ONLY NORMAL SALINE WAS BEING USED WHEN LEAKING WAS NOTICED. NO PATIENT WAS INVOLVED IN THIS EVENT. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7602660 ↗
• MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected; Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected

  THE DISTRIBUTOR REPORTED AN FILTER LEAKING ISSUE OF THE ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2018: "SOMETIMES THE TUBING LEAKS. AND, IT'S VERY HARD TO PRIME THE TUBING BECAUSE IT BUBBLES SO MUCH". THE DISTRIBUTOR ALSO FORWARDED A PICTURE TAKEN BY THE USER FACILITY THAT "THE TUBING WAS LEAKING RIGHT UNDER MY THUMB ON THE TOP PART OF THE TUBING". ZYNO MEDICAL WAS ABLE TO FOLLOW-UP WITH THE REPRESENTATIVE AT THE USER FACILITY ON (B)(6) 2018 AND OBTAINED THE FOLLOWING RESPONSE: "THE TUBING IS VERY HARD TO PRIME. EVEN WHEN IT'S JUST SALINE GOING THROUGH THE LINE. IT BUBBLES SO MUCH WE WASTE A GOOD BIT OF SALINE. THE CONNECTIVE PART WHERE THE LUER LOCK GOES INTO THE Y- SITE COMES APART AND SOMETIMES IT WILL NOT DISCONNECT. WE HAD A PATIENT GETTING READY TO RECEIVE THEIR DOXORUBICIN AND THE TUBING RIGHT BELOW THE CHAMBER WAS LEAKING. THIS DRUG IS A CAN CAUSE SERIOUS HARM TO THE SKIN. WE NOTICED THESE PROBLEMS WHEN WE RECEIVED THE NEW TUBING MANUFACTURED FROM CHINA. THE REF# (B)(4), LOT # 1601009". THE USER FACILITY REPRESENTATIVE CONFIRMED THAT NO PATIENT HARM OCCURRED: "WE FOUND THE PROBLEMS BEFORE IT EVER GOT TO THE PT". THE USER FACILITY REPRESENTATIVE REPORTED THAT THE AFFECTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7562525 ↗
• 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 7207907 ↗
• 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 (B)(4) 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 (B)(4) 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

  Patient problems: No Patient Involvement

  MAUDE report 7207906 ↗
• MalfunctionJan 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE INITIAL REPORTER REPORTED AN AIR-IN-LINE MISSED ALARM ISSUE CAUSED BY ADMINISTRATION SET TUBING TO ZYNO MEDICAL ON (B)(6) 2017. THE INITIAL REPORTER FORWARDED TO ZYNO MEDICAL THE EMAIL FROM THE REPRESENTATIVE AT THE USER FACILITY SENT OUT ON (B)(6) 2017: "WE HAD AN INCIDENT TODAY WITH A ZYNO PUMP THAT CONTINUED TO INFUSE, AFTER MEDICATION WAS COMPLETE. THE ENTIRE LINE ON THE MEDICATION WAS FILLED WITH AIR. I AM LABELING THE PUMP FOR EVALUATION." ON (B)(6) 2017 THE INITIAL REPORTER RECEIVED ANOTHER EMAIL FROM THE NURSE INVOLVED IN THIS EVENT AND FORWARDED TO ZYNO MEDICAL: "(B)(6) 2017 1348: PT STATED "THERE IS AIR IN THE TUBING" AND HE WAS POINTING HIS FINGER TO THE UPPER CHAMBER OF HIS GAMMAGARD TUBING. THE BOTTLE OF GAMMAGARD WAS NOTED TO BE EMPTY. I NOTED AIR THROUGHOUT THE IV TUBING FROM THE EMPTY 30GM GAMMAGARD BOTTLE TO THE IV SITE. I WITHDREW APPROXIMATELY 1ML AIR WITH A 3ML SYRINGE FROM HIS IV SITE. PT VERBALIZED HE WAS FEELING FINE AND DENIED LIGHTHEADEDNESS, DIZZINESS, VISION ISSUES, SHORT OF BREATH, CHEST PAIN. PT WAS INSTRUCTED IF HE DEVELOPS ANY OF THESE ISSUES TO CALL OUR OFFICE OR CALL 911 IF HE FEELS IT IS URGENT. PT VERBALIZED GOOD UNDERSTANDING OF ALL INFORMATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207894 ↗
• MalfunctionJan 19, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  THE INITIAL REPORTER REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET AT THE DRIP CHAMBER TO ZYNO MEDICAL ON (B)(4) 2018:" THERE WAS ANOTHER TUBING THAT LEAKED JUST NOW FROM THE SAME PLACE. JUST RIGHT UNDER THE BARREL. B2-70071-D. LOT 1606009 201908". THE INITIAL REPORTER ALSO MENTIONED THAT THE FAILED SET WAS NOT SAVED: "DIDN'T KNOW IF I WAS GOING TO NEED TO SEND THAT ONE IN AS WELL. NEXT TIME, I WILL SAVE ALL." NO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7207892 ↗
• 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 01/08/2018. A REGISTERED PHARMACY TECHNICIAN AT A USER FACILITY NOTIFIED A DISTRIBUTOR ON (B)(6) 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 (B)(6) 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 01/08/2018 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 Consequences Or Impact To Patient

  MAUDE report 7207884 ↗
• MalfunctionJan 19, 2018Device Operates Differently Than Expected; Infusion or Flow Problem; No Flow; Device Operates Differently Than Expected; Infusion or Flow Problem; No Flow

  THE INITIAL REPORTER FROM THE DISTRIBUTOR FACILITY CALLED ABOUT A SECONDARY LINE INFUSION RATE ISSUE OF THE DEVICE TO ZYNO MEDICAL ON (B)(6) 2018. THE EMAIL FROM THE INITIAL REPORTER IS AS BELOW: "BELOW IS THE CONTACT INFORMATION FOR THE NURSING SUPERVISOR FOR THE (B)(6) LOCATION THAT THE PATIENT INCIDENT WE DISCUSSED OCCURRED AT. WE PICKED UP THE PUMP FROM THE ACCOUNT ON (B)(6) AND IT WAS SHIPPED TO MY ATTENTION IN (B)(6). I DID A QUICK BENCH TEST AT THE PATIENT SETTING THAT WERE IN THE PUMP AND THE AIR IN LICE ALARM FUNCTIONED NORMALLY. I ALSO HAVE THE SET THAT WAS IN THE PUMP AT THE ACCOUNT SO I'LL SEND THAT ALONG FOR THE INVESTIGATION." THE INITIAL REPORTER PROVIDED THE FOLLOWING EVENT DESCRIPTION FROM THE NURSING SUPERVISOR AT THE LOCATION OF THE EVENT THROUGH EMAIL: "ON (B)(6) 2018, WE HAD A PATIENT IN OUR INFUSION ROOM TO RECEIVE ADRIAMYCIN AND CYTOXAN CHEMOTHERAPY. A PRIMARY IV BAG OF NORMAL SALINE 250ML WAS HUNG FOR PATIENT. PATIENT WAS GIVEN PREMEDICATIONS OF ALOXI AND DECADRON IN A 50ML SECONDARY BAG OVER 15 MINUTES. PATIENT WAS THEN GIVEN ADRIAMYCIN IV PUSH OVER 10 MINUTES VIA FREE FLOWING IV. AT 1413, CYTOXAN 1070 MG (53.5ML OF DRUG) DILUTED IN 250ML OF NORMAL SALINE W

  Patient problems: Chest Pain; Pain

  MAUDE report 7207881 ↗
• MalfunctionAug 10, 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 (3006575795-2017-00253).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6785795 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED LEAKING AT THE DRIP CHAMBER OF THE IV SET. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247665 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED LEAKING AT THE DRIP CHAMBER OF THE IV SET. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247655 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED A LEAKING ISSUE THAT THE LEAKAGE CAME FROM THE CONNECTION BETWEEN THE TUBING AND THE DRIP CHAMBER. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247651 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED LEAKING ISSUES OF IV SETS. "RECENT SETS ARE LEAKING WHERE THE TUBING GOES INTO THE DRIP CHAMBER. THERE HAVE BEEN AT LEAST A DOZEN AND PROBABLY MORE THAT HAVE NOT BEEN REPORTED. IN FACT ONE NURSE STATED THAT SHE WALKED PAST A PATIENT GETTING FLUIDS AND THE TUBING HAD COMPLETELY PULLED APART FROMTHE DRIP CHAMBER AND IT WAS FREE FLOWING. AS YOU CAN IMAGINE THIS IS AN EMERGENT SITUATION THAT WE REALLY CANNOT AFFORD TO CONTINUE WITH AND STILL MAINTAIN SAFETY FOR OUR PATIENTS AND STAFF." NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247639 ↗

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-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
• 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