ICU Medical 20124-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619023331), received between Sep 17, 2020 and Jun 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  INT'L.(CANADA)COMPLAINT RECEIVED REGARDING LEAKAGE ISSUES WITH ONE 20124-01 30" 20 DROP SPIROS ADMIN SET. IT WAS REPORTED THAT "LEAKING DISCOVERED DURING BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554706 ↗
• MalfunctionDec 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, SPIROS®, BAG HANGER. JUST BELOW THE DRIP CHAMBER, THE TUBING OF THE DEVICE WAS REPORTED AS CRACKED AND SPLIT WHICH RESULTED IN A CHEMOTHERAPY (CARPBOPLATIN) SPILL. THE PRODUCT WAS IN USE FOR ZERO HOURS AND THE EVENT HAPPENED DURING PRIMING. A CODE BROWN WAS CALLED. CHEMOTHERAPY SPILLED ON A STAFF MEMBER AND ONTO THE FLOOR OF THE CHEMO SUITE. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY. THERE WAS NO ADVERSE EVENT REPORTED AND THERE WAS NO HARMED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307734 ↗
• MalfunctionSep 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, SPIROS®, BAG HANGER THAT THE CUSTOMER REPORTED PARTICULATE WAS FOUND IN THE SET. THE CUSTOMER VISUALIZED A PIECE OF WHAT LOOKS LIKE CARDBOARD IN THE DRIP CHAMBER THAT WAS NOTICED AFTER ATTACHING A BAG PRIOR TO ADDING MEDICATION DURING THE LINE PRIMING STEP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10551026 ↗

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