NRFit 21-7605-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586044113), received between May 12, 2020 and Sep 25, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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.

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.

• MalfunctionSep 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900934 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848307 ↗
• MalfunctionSep 1, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550844 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LIQUID LEAKAGE WAS OBSERVED FROM THE BASE OF THE TUBE OF THE NRFIT EXTENSION SET DURING LIQUID FILLING. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621375 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE FROM THE CONNECTION PART BETWEEN THE TUBE AND THE CONNECTOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259099 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN ANAPAIN INJECTION WAS FILLED INTO THE CASSETTE, IT WAS DISCOVERED THAT LIQUID WAS LEAKING FROM THE JOINT BETWEEN THE CONNECTOR AND THE TUBE. THE EVENT OCCURRED BEFORE PATIENT USE AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546101 ↗
• MalfunctionOct 27, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AN OCCLUSION OCCURRED DURING PATIENT USE/ADMINISTRATION. THE ISSUE WAS RESOLVED BY REPLACING THE SET. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394308 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE HOSE RUNNING BETWEEN THE FILTER AND THE CASSETTE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627206 ↗
• MalfunctionNov 1, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, WHEN THE PCEA IS CONNECTED, AN ALARM SOUNDS, WHICH IS THOUGHT TO BE DUE TO A BLOCKAGE. AFTER REPLACING IT WITH ANOTHER EXTENSION TUBE, THERE ARE NO PROBLEMS. THIS OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20589767 ↗
• MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AFTER SWITCHING TO ELECTRODERMAL ACTIVITY (EDA) AND SPINAL WITH NRFIT CONNECTION, THERE HAVE BEEN A FEW INCIDENTS DURING EDA LAYING WHERE THE HOSES HAVE BEEN CONNECTED INCORRECTLY, WHICH HAS RESULTED IN OCCLUSION AND PUMP ALARMS. IT WAS STATED THAT ON THE PREVIOUS HOSES, IT HAD BEEN CLEARLY MARKED WHICH CONNECTION SHOULD GO TO WHICH AS THEY HAVE BEEN ABLE TO THINK "COLOR TO COLOR" (RED TO BLUE) AND AS ALL CONNECTIONS ARE NOW YELLOW, IT WILL RESULT IN ERRORS. IN ADDITION, THE HOSES ARE VERY LONG, THE ONES THEY HAD BEFORE WERE 113 CM, NOW THEY ARE SIGNIFICANTLY LONGER, 223 CM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484624 ↗
• MalfunctionJul 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A BLOCKAGE DURING LIQUID DELIVERY. PER REPORTER, THE PROBLEM WAS RESOLVED BY REPLACING THE TUBE AND THIS EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656154 ↗
• MalfunctionJul 2, 2024Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PUMP ALARMED, "BLOCKAGE AND NO FLOW," AND THE TUBE ORIENTATION WAS CHECKED. PER REPORTER, THIS OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655262 ↗
• MalfunctionJun 26, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A BLOCKAGE AND NO FLOW. PER REPORTER, THE TUBE ORIENTATION WAS CHECKED AND THE EVENT OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619846 ↗
• MalfunctionAug 30, 2023No Flow; No Flow

  IT WAS REPORTED THE DISPOSABLE'S MEDICINAL SOLUTION DOES NOT FLOW. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17654739 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED, THAT DURING THE USE OF THE PRODUCT. LEAKAGE OF MEDICAL FLUID FROM THE CONNECTION PART WAS OBSERVED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118733 ↗
• MalfunctionMay 11, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE THE DISPOSABLE CASSETTE TUBING BECAME DISCONNECTED FROM THE EXTENSIONS SET. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908907 ↗
• MalfunctionOct 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF MEDICAL FLUID FROM THE CONNECTOR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655091 ↗
• MalfunctionMay 23, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT (AN EXTENSION SET), AN OCCLUSION ALARM SOUNDED OVER AND OVER AGAIN. AFTER THE CUSTOMER CHANGED THE PRODUCT TO ANOTHER ONE, THE ALARM WAS CLEARED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470386 ↗
• MalfunctionMay 23, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT (AN EXTENSION SET), AN OCCLUSION ALARM SOUNDED OVER AND OVER AGAIN. AFTER THE CUSTOMER CHANGED THE PRODUCT TO ANOTHER ONE, THE ALARM WAS CLEARED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470377 ↗
• MalfunctionApr 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "DURING THE USE OF THE PRODUCT, LEAKAGE OF MEDICAL FLUID FROM THE CONNECTION PART (WHERE THE TUBING AND THE MEDIATION BAG WERE CONNECTED) WAS OBSERVED." NO PATIENT INJURY WAS REPORTED. *NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111662 ↗
• MalfunctionDec 1, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, THE CASSETTE TUBING BECAME DISCONNECTED FROM THE EXTENSIONS SET. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909027 ↗
• MalfunctionNov 23, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, LEAKAGE OF MEDICAL FLUID WAS NOTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12862345 ↗
• MalfunctionJul 13, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING DURING USE OF THE SMITHS MEDICAL CADD EXTENSION SET, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE CONNECTION PART. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158013 ↗
• MalfunctionSep 29, 2020Break; Disconnection; Break; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET FROM THE 250ML MEDICATION CASSETTE WAS DISCONNECTED DURING USE AND THE CUSTOMER NOTICED THAT THE EXTENSION TUBE'S CONNECTOR BROKE OFF. THERE BROKEN PART STAYED IN THE CASSETTE'S CONNECTOR. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Information

  MAUDE report 10601135 ↗
• MalfunctionSep 25, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT COMPLAINED OF PAIN AND IT'S POSSIBLE THAT MEDICATION HAS NOT BEEN PASSING THROUGH THE CADD EXTENSION SET. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589227 ↗

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
• Z-0965-2023 · Dec 9, 2022 · Open, Classified
  CADD 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