Zyno B2-70072-FRecalls & reported problems
Zyno Medical LLC · B2 Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zyno B2 primary IV administration set is used with Zyno infusion pumps. The 25 reports mostly describe leaks, including filter leaks and cracked or burst tubing, sometimes interrupting infusion; they mention no deaths and no injuries. One recall, closed in May 2019, involved an inverted clamp that could reverse fluid flow and draw blood from a patient when used with a secondary set.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10814371020201), received between Jan 6, 2017 and Jun 17, 2024 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 29, 2019Class IITerminated
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-2059-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash10
- Fluid/Blood Leak7
- Device Operates Differently Than Expected5
- Burst Container or Vessel4
- Material Integrity Problem3
- Component Misassembled2
- Device Misassembled During Manufacturing /Shipping2
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Not Applicable2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2024Contamination; Contamination
05/29/2024, INFUTRONIX MEDICAL RECEIVED A REPORT FROM THE CUSTOMER THAT ONE OF THE CASES/POUCH HAD BEEN PHYSICALLY DAMAGED B2-70072-F. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19554481 ↗MalfunctionJan 19, 2024Leak/Splash; Leak/Splash
ON 01/15/2024, INFUTRONIX RECEIVED A REPORT THAT AN ZYNO IV ADMINISTRATION SET HAD A FILTER-LEAKAGE ISSUE DURING INFUSION, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUEST THE IV ADMINISTRATION SET TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542645 ↗MalfunctionJan 19, 2024Leak/Splash; Leak/Splash
ON 01/15/2024, INFUTRONIX RECEIVED A REPORT THAT AN IV ADMINISTRATION SET HAD A LEAKAGE ISSUE DUE TO FILTER DURING INFUSION, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUEST THE IV ADMINISTRATION SET TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542644 ↗MalfunctionJan 19, 2024Leak/Splash; Leak/Splash
ON 01/15/2024, INFUTRONIX RECEIVED A REPORT THAT AN IV ADMINISTRATION SET HAD A LEAKAGE/FILTER ISSUE DURING INFUSION, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUEST THE IV ADMINISTRATION SET TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542588 ↗MalfunctionJan 19, 2024Leak/Splash; Leak/Splash
ON 01/15/2024, INFUTRONIX RECEIVED A REPORT THAT AN IV ADMINISTRATION SET HAD A LEAKAGE ISSUE (FILTER ISSUE) DURING INFUSION, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUEST THE IV ADMINISTRATION SET TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542586 ↗MalfunctionSep 15, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP WAS CRACKED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SET IS CRACKED AND LEAKING. THE CRACK IS NOT EVIDENT WHEN BAG IS PRIMED OR WHEN FIRST HUNG AND PUMP STARTED. TYPICALLY OCCURS AFTER THE INFUSION HAS BEEN RUNNING FOR A LITTLE WHILE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478187 ↗MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00040).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12409290 ↗MalfunctionJun 23, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: B2-70072-F. BATCH NO: 20036534. IT WAS REPORTED BY THE NURSE THAT THIS SET LEAKED. PATIENT WAS NOT HARMED. EVENT DATE; (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12054788 ↗MalfunctionMay 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00027).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893227 ↗MalfunctionDec 3, 2020Fungus in Device Environment; Fungus in Device Environment
IT WAS REPORTED THAT MOLD WAS FOUND ON THE OUTSIDE OF 50 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN ADMINISTRATION SET MODEL B2-70072-F LOT 17055890 WERE 6 MONTHS OUTSIDE OF THE EXPIRATION DATE SOME WERE SHOWING MOLD ON THE OUTSIDE OF THE PACKAGING. OPERATOR N/A. MEDICATION NONE. NO PATIENT INVOLVED. PATIENT NOT HARMED (B)(6) 2019."
Patient problems: No Patient Involvement
MAUDE report 10939461 ↗MalfunctionMay 22, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT "AN ADMINISTRATION SET MODEL B2-70072-F LOT 19126200 WAS LEAKING WHERE THE FILTER IS ATTACHED TO THE TUBING." A PATIENT WAS INVOLVED, BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS CEFTRIAXONE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10084462 ↗MalfunctionMar 24, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3006575795-2020-00003. THE ASSOCIATED ZYNO MEDICAL COMPLAINT NUMBER IS (B)(4). ON 04/06/2020, ZYNO MEDICAL RECEIVED A LETTER FROM FDA, WHICH PROVIDES ADDITIONAL INFORMATION REGARDING COMPLAINT (B)(4). THE LETTER IS TO NOTIFY ZYNO MEDICAL REGARDING A REPORT (MW5093332) IN FDA'S MEDWATCH PROGRAM. THE USER REPORTED THE FILTER-LEAKING ISSUE TO FDA ON (B)(6) 2020 STATING THAT " ZYNO MEDICAL ADMINISTRATION SET B2-70072-F FILTERS HAVE LEAKED CHEMOTHERAPY FROM THE FILTER 4 TIMES IN 2 WEEK PERIOD AT OUR PRACTICE LEADING TO CHEMO SPILLAGE AND PRODUCT WASTAGE". ZYNO MEDICAL HAS ALREADY FILED AN INITIAL MDR FOR THIS EVENT ON (B)(6) 2020. THIS FOLLOW-UP REPORT IS TO INCLUDE THE ADDITIONAL INFORMATION PROVIDED BY THE FDA LETTER AND PROVIDE CORRECTED DATA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9871128 ↗MalfunctionFeb 27, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00002).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9765729 ↗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
ZYNO MEDICAL RECEIVED A ROLLER CLAMP ISSUE AND A PINCH CLAMP ISSUE OF THE ADMINISTRATION SET FROM A DISTRIBUTOR REPRESENTATIVE ON 04/18/2019. THE DISTRIBUTOR REPRESENTATIVE FORWARDED AN EMAIL ON 04/18/2019 FROM THE USER FACILITY, WHICH STATED: "WHEN YOU OPEN THE FILTERED TUBING YOU WILL NOTICE THE ROLL CLAMP IN UPSIDE DOWN AND SEQUENCED WRONG. THE CLAMP THAT 'GOES IN THE PUMP' IS ALSO UPSIDE DOWN AND SEQUENCED WRONG ON THE TUBING." ON 04/19/2019 THE DISTRIBUTOR WAS ABLE TO CONNECT WITH THE NURSE MANAGER AT THE USER FACILITY WHERE THE ISSUE WAS DISCOVERED AND WHO REPORTED THAT A TOTAL OF TWO ADMINISTRATION SETS WERE FOUND WITH THE EXACT SAME ISSUE. THE NURSE MANAGER ALSO REPORTED THAT THE DEVICE OPERATOR WAS A NURSE AND THE ISSUE WAS NOTICED ON (B)(6) 2019. THE NURSE MANAGER CONFIRMED THAT NO PATIENT WAS INVOLVED AND NO MEDICATION WAS BEING INFUSED. THE NURSE MANAGER HAD ONE SET IN POSSESSION WHEREAS THE OTHER DEVICE HAD BEEN DISCARDED. THE DISTRIBUTOR ALSO STATED THE FOLLOWING: "THE ORDER AND ORIENTATION OF TWO PARTS ARE INCORRECT: ROLLER CLAMP AND PINCH CLAMP. THE ORDER ON THE PROBLEMATIC SETS WAS DESCRIBED AS FOLLOWS: SPIKE - BACK CHECK VALVE - Y-SITE - ROLLER CLAMP (SKINNY END F
Patient problems: No Patient Involvement
MAUDE report 8579668 ↗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 REPORT FOR THE INITIALLY SUBMITTED MDR (3006575795-2019-00008).
Patient problems: No Patient Involvement
MAUDE report 8579648 ↗MalfunctionDec 31, 2018Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem
ON (B)(6) 2018 A DISTRIBUTOR OF ZYNO MEDICAL FORWARDED A COMPLAINT RECEIVED FROM AN USER FACILITY ON (B)(6) 2018 ON FILTER BURST ISSUE OF THE DEVICE. THERE WERE TWO ADMINISTRATION SETS INVOLVED IN THIS INCIDENT, BOTH OF WHICH HAD THE MODEL NUMBER OF B2-70072-F AND THE LOT NUMBER OF 17096653. THE CUSTOMER SERVICE MANAGER AT THE USER FACILITY REPORTED THAT BOTH SETS BURST AT THE FILTER SITE WHILE 2 GRAMS OF CEFTRIAXONE WERE INFUSED, AND BOTH SETS WERE USED ON THE SAME PATIENT. DURING THE SECOND OCCURRENCE, THE TUBING BURST AT THE FILTER AND MEDICATION SPRAYED ON TO THE PATIENT'S FACE AND EYES. THE DIRECTOR OF NURSING AT THE USER FACILITY CONFIRMED ON (B)(6) 2018 THAT "NO ILL EFFECTS FROM RESIDENT WE IMMEDIATELY FLUSHED EYE PLUS HAS SOME EYE FLUSH AT HOME HUSBAND TO BRING. WE ARE GETTING HER A EYE DOCTOR APPT. JUST AS A EXTRA PRECAUTION." THE DIRECTOR OF NURSING ALSO STATED THAT THE AFFECTED DEVICE WAS DISCARDED AND COULD NOT BE FOUND ON (B)(6) 2018. ON (B)(6) 2018 THE DISTRIBUTOR RECEIVED FOLLOW-UP INFORMATION FROM THE NURSE DIRECTOR: "HAVE RECEIVED NEW TUBING. RESIDENT DOING FINE NO ILL EFFECTS IN FACT HAS BEEN IN AND OUT BUILDING ALL CHRISTMAS WITH HUSBAND." THE CONTRACT MANUFACTUR
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8206827 ↗MalfunctionDec 31, 2018Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem
ON (B)(6) 2018 A DISTRIBUTOR OF ZYNO MEDICAL FORWARDED A COMPLAINT RECEIVED FROM AN USER FACILITY ON (B)(6) 2018 ON FILTER BURST ISSUE OF THE DEVICE. THERE WERE TWO ADMINISTRATION SETS INVOLVED IN THIS INCIDENT, BOTH OF WHICH HAD THE MODEL NUMBER OF B2-70072-F AND THE LOT NUMBER OF 17096653. THE CUSTOMER SERVICE MANAGER AT THE USER FACILITY REPORTED THAT BOTH SETS BURST AT THE FILTER SITE WHILE 2 GRAMS OF CEFTRIAXONE WERE INFUSED, AND BOTH SETS WERE USED ON THE SAME PATIENT. DURING THE SECOND OCCURRENCE, THE TUBING BURST AT THE FILTER AND MEDICATION SPRAYED ON TO THE PATIENT'S FACE AND EYES. THE DIRECTOR OF NURSING AT THE USER FACILITY CONFIRMED ON (B)(6) 2018 THAT "NO ILL EFFECTS FROM RESIDENT WE IMMEDIATELY FLUSHED EYE PLUS HAS SOME EYE FLUSH AT HOME HUSBAND TO BRING. WE ARE GETTING HER A EYE DOCTOR APPT. JUST AS A EXTRA PRECAUTION." THE DIRECTOR OF NURSING ALSO STATED THAT THE AFFECTED DEVICE WAS DISCARDED AND COULD NOT BE FOUND ON (B)(6) 2018. ON (B)(6) 2018 THE DISTRIBUTOR RECEIVED FOLLOW-UP INFORMATION FROM THE NURSE DIRECTOR: "HAVE RECEIVED NEW TUBING. RESIDENT DOING FINE NO ILL EFFECTS IN FACT HAS BEEN IN AND OUT BUILDING ALL (B)(6) WITH HUSBAND." THE CONTRACT MANUFACTURER
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8206826 ↗MalfunctionMar 1, 2018Burst Container or Vessel; Device Displays Incorrect Message
ETOPOSIDE (VP16) WAS RUNNING ON A PUMP FOR A PATIENT. THE PUMP WAS ALARMING, SO THE RN CHECKED ON THE PUMP. PUMP READ OCCLUSION, SO THE TUBING WAS CHANGED, AND THE DRUG STARTED RUNNING AGAIN FOR SOME TIME. THE PUMP ALARMED FOR OCCLUSION AGAIN, SO THE RN CHECKED THE FILTER ON THE TUBING. THE FILTER EXPLODED, SPILLING ETOPOSIDE ON THE CHEMO GOWN, GOGGLES, IV POLE, AND FLOOR. A CHEMO SPILL KIT WAS USED TO CLEAN THE AREA. NO HARM CAME TO THE PATIENT AND TREATMENT WAS EVENTUALLY COMPLETED. THE FAULTY ADMINISTRATION SETS WERE NOT SAVED DUE TO THE CHEMOTHERAPY CONTAMINATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7305825 ↗MalfunctionSep 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER ORIGINALLY REPORTED AN OCCLUSION ISSUE OF THE ADMINISTRATION SETS ON (B)(6) 2017. DURING THE INVESTIGATION TESTING ON (B)(6) 2017, ZYNO MEDICAL'S CONTRACT SUPPLIER FOUND A LEAKING ISSUE WITH ONE IV SET. WITH THE NEW FINDING OF THE LEAKING ISSUE, THIS COMPLAINT WAS DETERMINED AS MDR REPORTABLE ON (B)(6) 2017. THE INVESTIGATION REPORT WAS RECEIVED BY ZYNO MEDICAL ON (B)(6) 2017.
Patient problems: Not Applicable
MAUDE report 6886161 ↗MalfunctionJul 6, 2017Burst Container or Vessel; Crack; Fluid/Blood Leak; Device Operates Differently Than Expected; Material Integrity Problem; Burst Container or Vessel; Crack; Fluid/Blood Leak; Device Operates Differently Than Expected; Material Integrity Problem
THE USER REPORTED EXPERIENCING IV SET LEAKING ISSUE. "WE HAVE HAD COMPLAINTS ABOUT FLUID LEAKING OUT OF THE FILTER CASING OF THE 0.2 MICRON FILTER TUBING (REF: (B)(4)). ONE TIME THE FILTER CASING CRACKED OPEN ON THE SIDE AND FLUID SQUIRTED ACROSS THE PATIENT'S BED AND HIT THE WALL. WE JUST FINISHED DISPENSING TUBING FROM LOT 17017533 AND SWITCHED TO A NEW LOT NUMBER. I WILL HAVE TO CALL THE NURSE TO CONFIRM ABOUT PATIENT INJURY. BASED ON WHAT SHE TOLD ME, THERE MAY HAVE BEEN SOME DRUG LOSS, BUT SHE MENTIONED NO PHYSICAL INJURY. AND IT HAPPENED TO SEVERAL PATIENTS BECAUSE SHE SAID OTHER NURSES HAD COMPLAINED ABOUT THE SAME ISSUE. IT SOUNDS LIKE IT HAS BEEN HAPPENING OVER SEVERAL DAYS ON SEVERAL PATIENTS. WE WERE ALERTED OF THE ISSUE (B)(6) 2017 BECAUSE THEY HAD USED UP THEIR TUBING SUPPLY AND NEEDED US TO SEND MORE. BY AFFECTED IV SET, DO YOU WANT ONE OF THE LEAKING ONES OR SIMPLY ONE FROM THAT LOT NUMBER THAT WE HAD BEEN USING? FOR THE ONE PATIENT I HAVE A NAME FOR, HE WAS ON CEFEPIME. I WILL CALL THE FACILITY SHORTLY AND REMIND THEM ABOUT THE SLIDE CLAMP BEING A POSSIBLE SOURCE OF THE PROBLEM. THE NURSE MENTIONED THAT THEY HAVE HAD OCCLUSION ALERTS WHEN THEY USE THE SAME TUBING TO
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6690724 ↗MalfunctionFeb 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED THAT THEY WERE "HAVING AN ISSUE WITH THE TUBING SETS LEAKING EVEN THOUGH THEY ARE CLAMPED" AND "THEY ARE LEAKING BEFORE GETTING TO THE PUMPS". HE ALSO REPORTED THAT "THIS IS HAPPENING WITH ALL THREE SETS THAT WE USE" AND HE HAS "CLOSED ALL CLAMPS ON THE PRIMARY LINES AND IT STILL LEAKS". NO PATIENTS WERE INVOLVED AND VARIOUS MEDICATIONS WERE USED.
Patient problems: Not Applicable
MAUDE report 6331301 ↗MalfunctionJan 17, 2017Leak/Splash; Leak/Splash
THE USER REPORTED A LEAKING ISSUE AT THE FILTER 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 6258325 ↗MalfunctionJan 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00012).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6258238 ↗MalfunctionJan 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED " WE RECEIVED SEVERAL BOXES OF THE FILTERED TUBING, THAT IS HORRIBLE. EVERY INFUSION THAT WE USE THIS TUBING, IT ALWAYS COMES UP WITH AN ERROR ON THE PUMP AND THERE IS SO MUCH AIR IN THE LINE THAT WE HAVE TO RE-PRIME THE TUBING, WE ARE WASTING A LOT OF MEDICATION." "AIR IS GETTING INTO THE SET FROM AN UNKNOWN LOCATION. A PATIENT WAS INVOLVED BUT NOT HARMED."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6234104 ↗MalfunctionJan 6, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE USER REPORTED "WE HAD A BAG THAT LEAKED AT THE IN-LINE FILTER. PATIENT NOTICED A PUDDLE ON THE FLOOR BELOW THE IV BAG AFTER THE TREATMENT. THE PATIENT HAD NO ADVERSE EFFECT. WE ARE UNCERTAIN AS TO HOW MUCH OF THE ACTUAL DOSE THE PATIENT RECEIVED. "
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6230492 ↗
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 · TerminatedZyno 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 · TerminatedZyno 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-2894-2016 · Jul 29, 2016 · TerminatedZyno 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-2896-2016 · Jul 29, 2016 · TerminatedZyno 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 · TerminatedZyno 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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