ICU Medical CH3128Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619024802), received between Jan 20, 2023 and Jan 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K173477); 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.

• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 30" (76 CM) APPX 5.9 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, 0.2 MICRON FILTER, SPIROS® W/RED CAP, HANGER WHERE IT LEAKED DOXORUBICIN + ETOPOSIDE + VINCRISTINE IN 0.9% SODIUM CHLORIDE FROM THE FILTER AREA ONTO THE TOP OF IV PUMP. THE TUBING WAS REPLACED OR RESTRUNG AND BAG REHUNG AND FINISHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE THIRD OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216205 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 30" (76 CM) APPX 5.9 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, 0.2 MICRON FILTER, SPIROS® W/RED CAP, HANGER WHERE IT LEAKED DOXORUBICIN + ETOPOSIDE + VINCRISTINE IN 0.9% SODIUM CHLORIDE FROM THE FILTER AREA ONTO THE TOP OF IV PUMP. THE TUBING WAS REPLACED OR RESTRUNG AND BAG REHUNG AND FINISHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE FIRST OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216199 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 30" (76 CM) APPX 5.9 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, 0.2 MICRON FILTER, SPIROS® W/RED CAP, HANGER WHERE IT LEAKED DOXORUBICIN + ETOPOSIDE + VINCRISTINE IN 0.9% SODIUM CHLORIDE FROM THE FILTER AREA ONTO THE TOP OF IV PUMP. THE TUBING WAS REPLACED OR RESTRUNG AND BAG REHUNG AND FINISHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE SECOND OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173477. One submission often covers many models, so check the product and lot details in each record.

• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-1580-2021 · Mar 16, 2021 · Open, Classified
  REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administrat
• Z-1578-2021 · Mar 16, 2021 · Open, Classified
  REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration o
• Z-1577-2021 · Mar 16, 2021 · Open, Classified
  REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1579-2021 · Mar 16, 2021 · Open, Classified
  REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a
• Z-1576-2021 · Mar 16, 2021 · Open, Classified
  REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-0704-2021 · Aug 31, 2020 · Open, Classified
  3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinn
• Z-0248-2021 · Jul 6, 2020 · Terminated
  6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149.