NRFit 21-7600-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of NRFit (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical NRFit infusion set is a medication cassette with tubing and connectors. Of its 90 reports, no deaths or injuries are recorded. Reports mostly describe fluid leaking at connectors and cassette lines, especially during priming. There were 34 reports in the last 12 months, up from 10 before. There are 4 open recalls covering tubing blockages and false alarms (2022), weak medication bag welds (2025), and connector leaks (2026).
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
- 94
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10610586044007), received between Jun 16, 2020 and Sep 24, 2026 — classified as 94 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (67 reports).
4 FDA recall records name this device's identifier, 4 still open.
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
- Aug 20, 2026Class IIOpen, Classified
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
Z-3212-2026 · Root cause: Process control · Recall details · FDA record ↗
- Aug 6, 2025Class IIOpen, Classified
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Z-2527-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 ↗
- 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
Device problems
- Fluid/Blood Leak67
- Leak/Splash14
- Obstruction of Flow4
- Volume Accuracy Problem4
- Insufficient Flow or Under Infusion3
- Break2
- Complete Blockage2
- Failure to Prime2
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Consequences Or Impact To Patient20
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that fluid leakage was observed from the base of the cassette connection port during priming. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886998 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874113 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874051 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that the NRFit CADD Medication Cassette leaking solution. The event occurred during priming. There was no patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867373 ↗MalfunctionSep 15, 2026Leak/Splash
It was stated there was a leak from the connector and tube connection. The event occurred during priming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777200 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599959 ↗MalfunctionJul 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105086 ↗MalfunctionJul 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT SOLUTION LEAKAGE WAS OBSERVED FROM THE CASSETTE LINE OF THE NRFIT 100 ML RESERVOIR CASSETTE BEFORE PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. IF THIS MALFUNCTION WERE TO OCCUR DURING PATIENT USE, IT COULD RESULT IN LEAKAGE OF DRUG, POTENTIALLY EXPOSING THE PATIENT AND/OR CLINICIAN TO THE MEDICATION AND AFFECTING THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696318 ↗MalfunctionJun 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING PRIMING, THE NRFIT MEDICATION CASSETTE HAD LEAKAGE NEAR THE CONNECTOR. THIS ISSUE POSES A POTENTIAL RISK BY CREATING A HAZARDOUS SITUATION FOR THE PATIENT, INCLUDING POSSIBLE EXPOSURE TO THE DRUG. THERE WAS NO PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586515 ↗MalfunctionJun 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT FLUID LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE TUBE AND THE CONNECTOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395202 ↗MalfunctionMay 21, 2026Fluid/Blood Leak
AN EVENT INVOLVING A NRFIT CADD 100ML EPID CASSETTES REPORTED THAT IN WHICH, UPON OPENING THE CASSETTE, FLUID LEAKAGE WAS OBSERVED FROM THE YELLOW CONNECTOR ATTACHED TO THE SYRINGE DURING DRUG FILLING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241784 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE OF LIQUID FROM THE BASE OF THE CONNECTOR THAT CONNECTS THE SYRINGE (TUBE JOINT PART) HAD OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177173 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016714 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016643 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016609 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016601 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016530 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016527 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016487 ↗MalfunctionApr 1, 2026Fluid/Blood Leak
IT WAS REPORTED THERE WAS LEAKAGE INSIDE THE CASSETTE. THE EVENT OCCURRED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758625 ↗MalfunctionMar 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE LEAKAGE HAPPENED FROM THE CONNECTION DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507897 ↗MalfunctionFeb 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART OF THE SYRINGE. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434897 ↗MalfunctionFeb 19, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE CASSETTE IS LEAKING AT THE CONNECTION OF THE TUBING AND THE YELLOW PLASTIC CONNECTOR DURING FILLING, IN THE PRODUCTION FACILITIES. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389405 ↗MalfunctionFeb 18, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS MEDICINE LIQUID LEAKAGE FROM THE CONNECTION PART OF THE TUBE CONNECTOR EXTENDING FROM THE MEDICATION CASSETTE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381345 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THERE WAS A LIQUID LEAKAGE FROM THE SIDE OF THE TUBE WHEN INJECTING THE SOLUTION. THIS DURING PRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368532 ↗
Other Administrations sets with neuraxial connectors devices
- NRFit 21-7609-24Icu Medical, Inc. · Administrations sets with neuraxial connectors3 recalls484 reports
- CADD 21-7649-24Icu Medical, Inc. · Administrations sets with neuraxial connectors2 recalls0 reports
- NRFit 21-7608-24Icu Medical, Inc. · Administrations sets with neuraxial connectors10 reports
- CADD 21-7665-24Icu Medical, Inc. · Administrations sets with neuraxial connectors1 report
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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