NRFit 21-7608-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of NRFit (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10610586043994), received between Feb 24, 2021 and Sep 16, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).
2 other recalls 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak8
- Obstruction of Flow2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795383 ↗MalfunctionApr 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT WHEN ATTEMPTING TO USE THE PRODUCT, IT WAS NOTICED THAT THERE WAS LIQUID LEAKING FROM THE BASE OF THE FILTER ON THE EXTENSION TUBE. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775450 ↗MalfunctionMar 18, 2026Obstruction of Flow
IT WAS REPORTED THAT IT WAS BLOCKED AND THE LIQUID MEDICINE COULD NOT PASS THROUGH OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630328 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
IT WAS STATED THAT THE CATHETER WAS LEAKING. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258816 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED NEAR THE CASSETTE-SIDE CONNECTION POINT. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201601 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN ATTEMPTING TO USE THE PRODUCT ON THE PATIENT, LIQUID LEAKAGE OCCURRED FROM THE EXTENSION TUBE. THIS ISSUE HAS HAPPENED MULTIPLE TIMES SO FAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705209 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LIQUID LEAK OCCURRED DURING PRIMING. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860844 ↗MalfunctionFeb 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LIQUID LEAK OCCURRED DURING PRIMING. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344507 ↗MalfunctionMar 23, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT CADD EXTENSION SETS, OCCLUSION ALARM DURING PRE-TEST. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869597 ↗MalfunctionFeb 24, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED REGARDING A CADD EXTENSION SET. IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE MEDICATION CASSETTE. THERE WAS NO PATIENT INJURIES NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11373540 ↗
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, ClassifiedCADD 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
- Z-0965-2023 · Dec 9, 2022 · Open, ClassifiedCADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-2
Other Administrations sets with neuraxial connectors devices
- NRFit 21-7609-24Icu Medical, Inc. · Administrations sets with neuraxial connectors3 recalls484 reports
- 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
- 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
- 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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