ICU Medical CH3227Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619025687), received between Apr 25, 2023 and Apr 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Air/Gas in Device; Air/Gas in Device

  A COMPLAINT WAS RECEIVED REGARDING A 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS®, BAG SPIKE, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER THAT EXPERIENCED AIR IN LINE. IT WAS STATED IN THE REPORT THAT ¿AIR IN LINE..¿ THE EVENT OCCURRED ON (B)(6) 2025, DURING INFUSION. THERE WAS CONCOMITANT DRUG USED, AND CONCOMITANT DEVICE INVOLVED. NO BLEEDBACK WAS NOTED AND THERE WAS NO DELAY IN CRITICAL THERAPY. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WERE 2 SAMPLES AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939431 ↗
• MalfunctionApr 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS¿, BAG SPIKE, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER WHERE IT WAS REPORTED THAT THE RUBBER SCRAPS FELL INTO THE TUBE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811987 ↗

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