NRFit 21-7609-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of NRFit (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical NRFit tubing set is used to deliver medicine. Its 479 adverse event reports mostly describe fluid leaking at connections, often during priming before use. There are no deaths and no injuries. Reports rose from 26 in the prior 12 months to 329 in the last 12. There are 3 open recalls: one for medication leaking at a connector, and two for tubing blockages that can under-deliver medicine.
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
- 484
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 484 adverse event reports that list this exact device (DI 10610586044014), received between May 13, 2020 and Sep 30, 2026 — classified as 484 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (407 reports).
3 FDA recall records name this device's identifier, 3 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 ↗
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Fluid/Blood Leak407
- Leak/Splash55
- Loss of or Failure to Bond13
- Insufficient Flow or Under Infusion9
- Break8
- Air/Gas in Device3
- Contamination2
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions441
- No Consequences Or Impact To Patient31
- No Patient Involvement6
- Insufficient Information3
- No Information3
Recent adverse event reports
The 25 most recent of 484 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952533 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951532 ↗MalfunctionSep 29, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940224 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891435 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was reported that fluid leakage was confirmed near the connection point between the medication cassette and the extension set. There was patient involvement; however, no additional adverse consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803901 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was reported that during medication filling, the leakage was observed on the NRFit medication cassette connection between the tube and connector. This issue poses a potential risk of leak and creates a hazardous situation for the patient, including possible exposure to the drug. There was a patient involvement; however, no harm/adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802815 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777105 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported that during priming, the drug solution was leaked from the connector to tubing connection. 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 and no harm/adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775421 ↗MalfunctionSep 7, 2026Fluid/Blood Leak; Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657257 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that the NRFit Cassette was leaking fluid occurred at the junction between the injection port and tubing. The event occurred before patient use at the facility. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476288 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166320 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166259 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166068 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165476 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164313 ↗MalfunctionAug 4, 2026Fluid/Blood Leak
It was reported that leakage of medicinal solution occurred during priming. There were no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131925 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
It was reported that the Luer-Lock adapter leaked despite being tightly secured. The issue affected patient care and was resolved by replacing the product. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114339 ↗MalfunctionJul 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105141 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024655 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024357 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50023307 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50018887 ↗MalfunctionJul 27, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013816 ↗MalfunctionJul 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25889647 ↗MalfunctionJul 20, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874688 ↗
Other Administrations sets with neuraxial connectors devices
- NRFit 21-7600-24Icu Medical, Inc. · Administrations sets with neuraxial connectors4 recalls94 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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