NRFit 21-7624-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10610586044748), received between Apr 13, 2021 and Mar 31, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K162219); 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.

Recalls naming this device

1. Dec 9, 2022Class IOpen, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 9, 2022Class IOpen, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0965-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT NRFIT ADMINISTRATION SET LEAKED LIQUID. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749275 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE DEVICE ALARMED WITH A RED SCREEN AND AIR IN THE TUBING WAS OBSERVED AT THE TIME OF THE ALARM. PER REPORTER, IT WAS THEN NOTICED THAT THE BAG WAS DAMP, AND REPORTER CLARIFIED THE AIR IN THE TUBBING WAS FROM THE PUMP AND DOWN A BIT, BUT NOT INTO THE PATIENT. THE BAG WAS REPLACED BUT THE ISSUE RECURRED. REPORTER STATED THE UNIT WAS REPLACED AND IT WAS THEN NOTICED THERE WAS A HOLE IN THE TUBING, RIGHT NEXT TO THE CONNECTOR THAT ATTACHES TO THE PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457459 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE BAG WAS REPLACED DUE TO AN ALARM/RED SCREEN ON THE PUMP ALONG WITH AIR IN THE LINE, AND THE ISSUE RECURRED WITH THE REPLACEMENT BAG. PER REPORTER, VISUAL INSPECTION WAS THEN PERFORMED, AND IT WAS NOTICED THERE WAS A HOLE IN THE TUBING, RIGHT NEXT TO THE CONNECTOR THAT ATTACHES TO THE PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457017 ↗
• MalfunctionAug 7, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION EVENT. EPIDURAL INFUSION VIA INTERMITTENT BOLUS, EVENT LOG SAYS 84ML DELIVERED AND BAG VOLUME 52ML AT END OF INFUSION (100ML BAG). THE REPORTER STATED THAT THE CNM IN MATERNITY HAS INFORMED HER THAT THERE WAS 52ML LEFT AT THE END OF THE TREATMENT. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE HARM REPORTED. POSSIBLE LOT NUMBER 6026769

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742620 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SINCE CASES OF INFECTION AT THE EPIDURAL CATHETER INSERTION SITE OCCUR APPROXIMATELY ONCE A MONTH, THE OPERATOR WOULD LIKE TO CONFIRM WHETHER THE PRODUCT WE ARE USING TOGETHER IS PROPERLY STERILIZED. THE EVENT OCCURRED DURING USE AND PATIENT WAS HARMED DUE TO HAVING AN INFECTION.

  Patient problems: Skin Infection

  MAUDE report 22162589 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PART OF THE TUBE WAS CUT, CAUSING LIQUID LEAKAGE DURING USE. THE EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061112 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING AT THE CLIP-ON LEAKED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018315 ↗
• MalfunctionApr 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS A WRONG LABEL USED IN THE SUPPLIED LUER SYSTEMS BOXES ¿ THE LABEL DESIGNATED THE CONTENT AS MALE NRFIT CONNECTION. THE CONTENTS OF THE BOXES ARE THE DESIRED LUER CONNECTION, BUT THE ITEM NAME IS INCORRECT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859335 ↗
• MalfunctionMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING AT THE CLIP-ON LEAKED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646900 ↗
• MalfunctionDec 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT STARTED LEAKING. THE MEDICINE ENDED UP ON THE FLOOR AND NOT IN THE HOSE. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021445 ↗
• MalfunctionOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PCA SET WAS LEAKING NEAR THE PUMP CASSETTE. THE CONCERN IS THAT THE PATIENT HAS NOT BEEN RECEIVING THE FULL/ANY OF THE DOSE WHEN PRESSING IT. THERE WAS PATIENT INVOLVEMENT, BUT NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343733 ↗
• MalfunctionDec 27, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN UPSTREAM OCCLUSION ALARM, AND THE EPIDURAL ANALGESIC INJECTION WAS STOPPED DUE TO THE ALARM THAT INVOLVED MULTIPLE PATIENTS. NO OCCLUSION WAS NOTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405524 ↗
• MalfunctionAug 28, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT UNDER DELIVERY OCCURRED DURING TESTING OF THE DEVICE ON A PATIENT. PER REPORTER A 220 ML RESERVOIR WAS USED AND IT WAS DISPLAYED THAT 10 ML REMAINED, HOWEVER, 100 ML REMAINED IN THE RESERVOIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17638551 ↗
• MalfunctionMay 26, 2023Complete Blockage; Product Quality Problem; Obstruction of Flow; Complete Blockage; Product Quality Problem; Obstruction of Flow

  IT WAS REPORTED THE DISPOSABLE CAUSED THE PUMP TO ALARM DOWNSTREAM OCCLUSION. THIS EVENT WAS REPORTED, DISPOSABLE TO BE CHANGED ON PATIENT. NO PATIENT INJURY. CUSTOMER IS DEALING WITH THE OCCLUSIONS IN HOUSE AND THEIR DELIVERY RATE FOR A BOLUS WAS SET TO 250ML PER HOUR AND HAS BEEN TO 125ML/HR TO SEE IF THAT CAUSES OCCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011774 ↗
• MalfunctionMay 26, 2023Complete Blockage; Product Quality Problem; Obstruction of Flow; Complete Blockage; Product Quality Problem; Obstruction of Flow

  IT WAS REPORTED THE DISPOSABLE CAUSED THE PUMP TO ALARM DOWNSTREAM OCCLUSION. THIS EVENT WAS REPORTED, DISPOSABLE TO BE CHANGED ON PATIENT. NO PATIENT INJURY. CUSTOMER IS DEALING WITH THE OCCLUSIONS IN HOUSE AND THEIR DELIVERY RATE FOR A BOLUS WAS SET TO 250ML PER HOUR AND HAS BEEN TO 125ML/HR TO SEE IF THAT CAUSES OCCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011599 ↗
• MalfunctionApr 20, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THE UPSTREAM OCCLUSION ALARM SOUNDED AFTER THE GIVING SET RUN THROUGH AND ONE BOLUS INTO PATIENT ADMINISTERED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776034 ↗
• MalfunctionOct 17, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE PUMP EXHIBITED A DEVICE WAS NOT ATTACHED PROPERLY ALARM. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617102 ↗
• MalfunctionJun 24, 2022Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK MEDICAL FLUID WOULD NOT PASS THROUGH THE DEVICE WHILE ATTEMPTING TO PRIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806771 ↗
• MalfunctionJun 9, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS PERFORMING A PRIMING DURING THE PRE-USE CHECK, HE NOTICED MEDICAL FLUID WOULD NOT PASS THROUGH THE PRODUCT. NO PATIENT WAS INVOLVED AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644572 ↗
• MalfunctionMay 11, 2022Complete Blockage; Blocked Connection; Complete Blockage; Blocked Connection

  IT WAS REPORTED THAT WHEN THE SUSPECT DEVICE WAS NOT FUNCTIONAL AFTER BEING ATTACHED TO THE CASSETTE. THERE WAS NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER, HOWEVER; NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365947 ↗
• MalfunctionMay 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKED FROM THE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309923 ↗
• MalfunctionApr 26, 2021Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, AN OCCLUSION ALARM SOUNDED. AFTER THE USER CHANGED THE CASSETTE TO ANOTHER ONE, THE ALARM WAS SETTLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729810 ↗
• MalfunctionApr 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER FOUND LEAKAGE SOMEWHERE FROM THE INFUSION LINE (THE EXACT LEAKING SPOT IS NOT CERTAIN). SO HE STOPPED USING THE PRODUCT; THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661315 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162219. One submission often covers many models, so check the product and lot details in each record.

• Z-3212-2026 · Aug 20, 2026 · Open, Classified
  CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24