Zyno A2-80071-DFRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10814371020072), received between Dec 22, 2016 and Dec 10, 2020 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED FROM THE FILTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED THAT AN ADMINISTRATION SET MODEL A2-80071-DF LOT 18036934 SET WAS LEAKING AT THE FILTER. OPERATOR RN. MEDICATION UNKNOWN. PATIENT INVOLVED. PATIENT WAS NOT HARMED. (B)(6) 2020".

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

  MAUDE report 10989258 ↗
• MalfunctionDec 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: A2-80071-DF, BATCH NO: 20036759. IT WAS REPORTED THAT AN ADMINISTRATION SET MODEL WAS LEAKING AT THE FILTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10939506 ↗
• MalfunctionOct 14, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00035).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10677357 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Leak/Splash; Improper Flow or Infusion; Fluid/Blood Leak; Leak/Splash; Improper Flow or Infusion

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00009).

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

  MAUDE report 10466723 ↗
• MalfunctionAug 6, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS IS A SECOND FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00008).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10377168 ↗
• MalfunctionJun 29, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON 6/8/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 6/1/2020 STATING THAT "AN ADMINISTRATION SET MODEL AX-80071-DF LOT 18036934 SET WAS LEAKING AT THE FILTER." A PATIENT WAS INVOLVED, BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED GAMMAGARD. THE DISTRIBUTOR REPRESENTATIVE LATER MADE A CORRECTION THAT THE MODEL NUMBER IS A2-80071-DF. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10209710 ↗
• MalfunctionDec 19, 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 AN EMAIL ON 12/05/2018, WHO STATED THAT "AN A2-80071-DF IV SET WAS LEAKING WHILE THE ROLLER CLAMP WAS CLOSED". THE CUSTOMER ALSO STATED THAT SHE DID NOT BELIEVE THAT THERE WAS ANY PATIENT INVOLVEMENT. DATE OF INCIDENT IS UNKNOWN. DEVICE OPERATOR IS UNKNOWN. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS BECTON DICKINSON.

  Patient problems: No Patient Involvement

  MAUDE report 8178633 ↗
• MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected; Fluid/Blood Leak; Leak/Splash; Device Operates Differently Than Expected

  ZYNO MEDICAL WAS NOTIFIED OF A FILTER LEAKING ISSUE ON (B)(6) 2018 FROM THE DISTRIBUTOR. THE USER'S DESCRIPTION OF THE INCIDENT WAS FORWARDED TO ZYNO MEDICAL AND IS AS FOLLOWS: "PATIENT'S DOSE OF ETOPOSIDE HAD COMPLETED. I WAS GENTLY HOLDING THE TUBING AND ROLLING THE ROLLER CLAMP CLOSED WHEN THE TUBING CAME APART AT THE TOP OF THE INLINE FILTER. APPROXIMATELY 10ML OF CHEMO WAS WASTED ON THE RECLINER. I IMMEDIATELY CLAMPED OFF THE CHEMO AND PROMPTLY CLEANED THE CHEMO OFF THE CHAIR USING BLEACH WIPES. CHEMOTHERAPY MADE CONTACT WITH THE RECLINER ONLY. A SMALL AMOUNT OF CHEMO FELL ON A PATIENT RECLINER, BUT NONE GOT ON THE PATIENT OR STAFF". THE DRUG BEING INFUSED WAS ETOPOSIDE. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE. THE DATE OF THE EVENT IS (B)(6) 2018. THE CONTRACT MANUFACTURE OF THE AFFECTED SET IS BECTON, DICKINSON AND COMPANY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7562524 ↗
• MalfunctionMay 24, 2018Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue; Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue

  A DISTRIBUTOR REPRESENTATIVE REPORTED A FILTER CRACK ISSUE TO ZYNO MEDICAL ON (B)(6) 2018: "I HAVE A CUSTOMER THAT IS HAVING PROBLEMS WITH HER TUBING. SHE IS GOING TO SEND IN SOME DEFECTIVE SETS TO ZYNO". INFORMATION FROM THE USER FACILITY WAS FORWARDED TO ZYNO MEDICAL: "I HAD ONE TUBING WITH A FILTER LOT #A2-80071-DF THAT WAS DEFECTED. THE FILTER EXPLODED AS I WAS FLUSHING THE TUBING". ON (B)(6) 2018 THE DISTRIBUTOR REPRESENTATIVE FORWARDED ADDITIONAL INFORMATION TO ZYNO MEDICAL: "I TRIED THOSE STEPS SEVERAL TIMES, BUT THAT DID NOT HELP. I WAS INFUSING ORENCIA. IT HAD 3 DEFECTIVE TUBINGS SETS. BUT I HAVE NEVER HAD THIS ISSUE EVER BEFORE WITH ANY OF MY DRUGS. I PRIME THE LINES OUTSIDE THE PUMP THEN PLACE IT IN THE PUMP. IT RUNS FOR ABOUT 15 MINUTES THEN IT ALARMS OCCLUSION. AFTER FLUSHING THE IV I RUN THE PUMP AGAIN WITH NO SUCCESS. I ALSO HAVE TRIED TO INFUSE VIA GRAVITY AND THERE IS NO FLOW. THE OCCLUSION IS IN THE FILTER. THERE WAS NOT ANY HARM TO THE PATIENT". ZYNO MEDICAL FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE WHO IS AN INFUSION NURSE MANAGER ON (B)(6) 2018 AND RECEIVED THE RESPONSE AS "THE DATES OF THE INCIDENTS WERE ON (B)(6). THE LOT NUMBER IS THE SAME ONE AS SEE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542027 ↗
• MalfunctionMay 24, 2018Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue; Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue

  A DISTRIBUTOR REPRESENTATIVE REPORTED A FILTER CRACK ISSUE TO ZYNO MEDICAL ON 05/10/2018: "I HAVE A CUSTOMER THAT IS HAVING PROBLEMS WITH HER TUBING. SHE IS GOING TO SEND IN SOME DEFECTIVE SETS TO ZYNO". INFORMATION FROM THE USER FACILITY WAS FORWARDED TO ZYNO MEDICAL: "I HAD ONE TUBING WITH A FILTER LOT #A2-80071-DF THAT WAS DEFECTED. THE FILTER EXPLODED AS I WAS FLUSHING THE TUBING". ON 05/11/2018 THE DISTRIBUTOR REPRESENTATIVE FORWARDED ADDITIONAL INFORMATION TO ZYNO MEDICAL: "I TRIED THOSE STEPS SEVERAL TIMES, BUT THAT DID NOT HELP. I WAS INFUSING ORENCIA. IT HAD 3 DEFECTIVE TUBINGS SETS. BUT I HAVE NEVER HAD THIS ISSUE EVER BEFORE WITH ANY OF MY DRUGS. I PRIME THE LINES OUTSIDE THE PUMP THEN PLACE IT IN THE PUMP. IT RUNS FOR ABOUT 15 MINUTES THEN IT ALARMS OCCLUSION. AFTER FLUSHING THE IV I RUN THE PUMP AGAIN WITH NO SUCCESS. I ALSO HAVE TRIED TO INFUSE VIA GRAVITY AND THERE IS NO FLOW. THE OCCLUSION IS IN THE FILTER. THERE WAS NOT ANY HARM TO THE PATIENT". ZYNO MEDICAL FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE WHO IS AN INFUSION NURSE MANAGER ON 05/14/2018 AND RECEIVED THE RESPONSE AS "THE DATES OF THE INCIDENTS WERE ON MAY 2 AND 9TH. THE LOT NUMBER IS THE SAME ONE AS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542026 ↗
• MalfunctionMay 24, 2018Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue; Crack; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Physical Property Issue

  A DISTRIBUTOR REPRESENTATIVE REPORTED A FILTER CRACK ISSUE TO ZYNO MEDICAL ON 05/10/2018: "I HAVE A CUSTOMER THAT IS HAVING PROBLEMS WITH HER TUBING. SHE IS GOING TO SEND IN SOME DEFECTIVE SETS TO ZYNO". INFORMATION FROM THE USER FACILITY WAS FORWARDED TO ZYNO MEDICAL: "I HAD ONE TUBING WITH A FILTER LOT #A2-80071-DF THAT WAS DEFECTED. THE FILTER EXPLODED AS I WAS FLUSHING THE TUBING". ON 05/11/2018 THE DISTRIBUTOR REPRESENTATIVE FORWARDED ADDITIONAL INFORMATION TO ZYNO MEDICAL: "I TRIED THOSE STEPS SEVERAL TIMES, BUT THAT DID NOT HELP. I WAS INFUSING ORENCIA. IT HAD 3 DEFECTIVE TUBINGS SETS. BUT I HAVE NEVER HAD THIS ISSUE EVER BEFORE WITH ANY OF MY DRUGS. I PRIME THE LINES OUTSIDE THE PUMP THEN PLACE IT IN THE PUMP. IT RUNS FOR ABOUT 15 MINUTES THEN IT ALARMS OCCLUSION. AFTER FLUSHING THE IV I RUN THE PUMP AGAIN WITH NO SUCCESS. I ALSO HAVE TRIED TO INFUSE VIA GRAVITY AND THERE IS NO FLOW. THE OCCLUSION IS IN THE FILTER. THERE WAS NOT ANY HARM TO THE PATIENT". ZYNO MEDICAL FOLLOWED UP WITH THE USER FACILITY REPRESENTATIVE WHO IS AN INFUSION NURSE MANAGER ON 05/14/2018 AND RECEIVED THE RESPONSE AS "THE DATES OF THE INCIDENTS WERE ON (B)(6). THE LOT NUMBER IS THE SAME ONE AS SEEN B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542019 ↗
• MalfunctionFeb 7, 2018Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected; Leak/Splash; Mechanical Problem; Device Operates Differently Than Expected

  A DISTRIBUTOR FORWARDED THE MESSAGE FROM A REPRESENTATIVE AT THE USER FACILITY REPORTING A FILTER LEAKING ISSUE TO ZYNO MEDICAL ON 01/31/2018. THE NURSE AT THE USER FACILITY FURTHER UPDATED THAT "WE HAVE BEEN HAVING SOME TROUBLE WITH THE FILTERS ON OR 80071-DF TUBING. THE FILTER MAKES A "SNAP" SOUND THE THEN STARTS LEAKING (YES, THE CLAMPS ARE OPEN!). A PATIENT ACTUALLY ALERTED THE NURSE SHE HEARD A "POP" AND THE NURSE INVESTIGATED AND FOUND CRACKED FILTER LEAKING. PT WAS NOT INJURED. THE SET WAS NOT SAVED BUT WILL SAVE ANY FUTURE ONES TO SEND BACK. UNCERTAIN OF EXACTLY WHICH PACKAGE THE MENTIONED TUBING CAME FROM." NO EVENT DATE WAS PROVIDED BY THE INITIAL REPORTER. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS BECTON DICKINSON. THE DISTRIBUTOR HAS CONFIRMED THAT THE MODEL NUMBER OF THE AFFECTED SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247344 ↗
• MalfunctionSep 22, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00273).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886158 ↗
• MalfunctionApr 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED THAT THE IV SET HAD A BROKEN FILTER. THE TUBING WAS USED FOR CHEMOTHERAPY ON A PATIENT AND THE SOLUTION WAS TAXOL. "IT WAS NOTICED AT THE FIFTEEN MINUTE VITAL CHECK THAT THERE WAS A PUDDLE OF FLUID ON THE FLOOR BY THE PATIENTS TREATMENT CHAIR. UPON FURTHER INVESTIGATION IT WAS NOTED THAT THIS WAS THE FILTER LEAKING". NO PATIENT HARM OR INJURY OCCURRED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6494726 ↗
• MalfunctionJan 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED A LEAKING ISSUE THAT THE TUBING "LEAK JUST BELOW THE FILTER HOUSING". NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6258593 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE TUBING WAS LEAKING AT THE FILTER. NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: Not Applicable

  MAUDE report 6247795 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT "I WANTED TO ALERT YOU TO ANOTHER INCIDENT WITH A CHEMO SPILL RELATED TO THE FILTER TUBING. THIS ONE WAS A LITTLE MORE SIGNIFICANT IN SIZE, COSTLIER, AND CAUSED REAL DISTRESS TO THE PATIENT AND HER SPOUSE." THE LEAKAGE AMOUNT WAS 40-50CC OF THE MEDICATION. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247657 ↗
• MalfunctionJan 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER REPORTED THE FOLLOWING INFORMATION: "PATIENT SET UP WITH AN IV OF TAXOL WITH THE ZYNO PUMP. · INFUSION LINE WAS LEAKING, LEAKING CAME FROM THE GREEN VENT; THIS WAS STILL APPARENT WHEN BROUGHT INTO THE PHARMACY FOR OUR INSPECTION; TUBING WAS REPLACED WITH A SECOND SET. · EMERGENCY DRUGS WERE IV PUSH AND DONE AT THE LOWER PORT. · TAXOL WAS DISCONNECTED. THIS WAS TO PREVENT ANY MORE TAXOL FROM ACCIDENTALLY INFUSING. · A SECOND SET WAS OPENED. THIS WAS THE SECOND SET OF TUBING. THE LOWER Y SITE, THAT IS PART OF THE HUBER NEEDLE SET UP (THIS IS WHERE THE TAXOL FILTER TUBING WAS CONNECTED) DID NOT BREAK, THE TAXOL FILTER TUBING BROKE OFF INTO THE ACTUALLY LUER LOCK OF THE Y SITE CAUSING THE BLUE ACCORDION TO REMAIN COMPRESSED SO WHEN EMERGENCY MEDS WERE GIVEN, IT LEAKED OUT OF THIS Y SITE. THEREFORE A NEW IV (PORT ACCESS) HAD TO BE STARTED. " NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS EVENT. THE USER REPORTED A LEAKING ISSUE FROM THE AIR VENT OF ZYNO'S IV SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6244135 ↗
• MalfunctionJan 9, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER HAD 2 INCIDENTS OF LEAKING AT THE FILTER ON A2-80071-DF (IV SET) BOTH LOT #1410004. NO PATIENTS WERE INJURED BUT THE USER DID HAVE CHEMO SPILL ONTO THE FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6234093 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE USER REPORTED "WE HAD AN INCIDENT. THE CLAMP WAS CLOSED AND THE PUMP DID NOT BEEP OCCLUSION. THEREFORE THE CONNECTION BETWEEN THE TUBING AND FILTER CREATED A LEAK AND WE HAD A CHEMO SPILL. " THIS IS AN ISSUE WITH LEAKY IV SETS. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233083 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED "IV SETS LEAKING AT THE FILTER. NO PATIENT INJURY OR HARM WAS INVOLVED, JUST SOME WET PANTS AND A SMALL LOSS OF DRUG." NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233075 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE USER REPORTED " OVER THE PAST TWO MONTH TWO(2) A2-80071-DF IV SETS LEAKED ABOVE THE FILTER WHERE THE TUBING MEETS THE FILTER. THE LOT # WAS NOT OBTAINED FOR THE FIRST LEAKING INCIDENT BUT A PATIENT WAS INVOLVED AND NO INJURIES OR HARM OF THE PATIENT WAS REPORTED." NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233056 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE USER REPORTED "WE HAVE HAD SOME MAJOR ISSUES WITH THIS NEW TUBING. PATIENT WAS RECEIVING ERBITOX AND APPROXIMATELY 50 ML OF LIQUID ON GROUND, APPEARED TO ORIGINATE FROM FILTER ON TUBING. CHEMO SPILL KIT WAS USED TO MANAGE AREA PER POLICY. WE HAVE HAD FOUR CHEMO SPILLS IN THE PAST TWO WEEKS." NO PATIENT INJURY OR HARM WAS INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233051 ↗
• MalfunctionJan 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE A2-80071-DF MODEL TUBINGS HAD BEEN LEAKING AT THE FILTER ABOUT 40% OF THE TIME FOR THE LAST 3 MONTHS. THEY HAD EVEN SEEN CRACKS IN THE FILTERS. THEY ALSO THOUGHT THAT AIR WAS GETTING TRAPPED IN THE FILTERS. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233050 ↗
• MalfunctionJan 6, 2017Leak/Splash; Leak/Splash

  THE USER REPORTED "WE HAD A NUMBER OF ISSUES WITH THE FILTER TUBING LEAKING. AFTER LOOKING AT THE TUBING, IT SEEMS TO BE LEAKING FROM WHERE THE TWO PIECES COME TOGETHER, COVERING THE FILTER ( I AM NOT SURE IF THESE TWO PIECES ARE GLUED TOGETHER OR WHAT.)" THE USER ALSO STATED: "THIS EVENT HAS HAPPENED SEVERAL TIMES, AND HAS CAUSED SERIOUS CONCERNS WITHIN OUR COMPANY. THIS IS NOT ONLY A LIABILITY FOR US, BUT ALSO A SERIOUS SAFETY CONCERN FOR PATIENTS, AS WELL AS EMPLOYEES. FOR OUR STANDPOINT THIS PRODUCT HAS PROVEN TO BE INADEQUATE, AND WE NEED SWIFT RESOLUTION FORM ZYNO MEDICAL AT THIS TIME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6230427 ↗

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-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