ICU Medical CH3225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619025663), received between Aug 12, 2025 and Dec 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K070532); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A 14 APPX 8.0 ML, QUINFUSE ADD-ON SET, BAG SPIKE, 5 CLAMPS, DRY SPIKE ADAPTER REPORTED LEAKAGE FROM THE END OF ADMINISTRATION SET. EVENT WAS NOTED DURING INFUSION. AN UNKNOWN CHEMO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO BLEED BACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RE STERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY. THIS REPORT CAPTURES TEN OCCURRENCES INVOLVING THE SAME DEVICE MODEL. NO ADDITIONAL IDENTIFYING INFORMATION WAS AVAILABLE FOR ANY OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764914 ↗
• MalfunctionAug 12, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  EVENT OCCURRED REGARDING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THEY REPORTED THEY FOUND THE PRODUCT IN THE PACKAGE IS CH3226 INSTEAD OF CH3225. DEVICE WAS NOT USE FOR CHEMO. ONLY ONE (1) DEVICE WAS REPORTED FOR THIS COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789617 ↗
• MalfunctionAug 12, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  EVENT OCCURRED REGARDING 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (BLUE, 4 RED), DRY SPIKE ADAPTER WHERE THEY REPORTED THAT DURING INFUSION OF A MITOXANTRONE, LIQUID WAS STILL DRIPPING EVEN AFTER CLOSING THE RED CLAMP. DEVICE WAS USE FOR CHEMO. ONLY ONE (1) DEVICE WAS AFFECTED IN THIS REPORT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781954 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE