ICU Medical CH-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619025854), received between Aug 1, 2019 and Oct 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION AS FOLLOWS: WHILE MAKING UP IMMUNOTHERAPY AND DRAWING UP THE TREATMENT IN A CLOSED SYSTEM VIA A SYRINGE, THE CHEMO CLAVE UNIVERSAL VENTED SPIKE SHOT THE IMMUNOTHERAPY OUT OF A CRACK IN THE SIDE OF THE EQUIPMENT THAT WAS DISCOVERED TO BE DEFECTIVE. THIS WENT ON THE PREPARER'S GLOVES AND A PUDDLE OF IMMUNOTHERAPY WAS PRESENT IN THE BLUE CLINICAL TRAY. THE PRODUCT WAS STORED IN ROOM TEMPERATURE IN THE STOREROOM INSIDE OF A CUPBOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478440 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOCLAVE¿ UNIVERSAL VENTED VIAL SPIKE WHERE A SPILL OF CHEMOTHERAPY DRUG WAS NOTED FROM HOLE OF THE FILTER DURING THE ASPIRATION PHASE. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396166 ↗
• MalfunctionFeb 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE THAT DURING ASPIRATION, USING A SYRINGE OF OXALIPLATIN, A LEAK WAS NOTED FROM THE SPIKE CONTAMINATING THE WORK AREA HOOD AND THE OPERATOR¿S FOREARM¿. THERE IS PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 9670691 ↗
• MalfunctionAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE DATE OF THE EVENT IS UNKNOWN. THE PRODUCT INVOLVED IS AN ICU MEDICAL CHEMOCLAVE UNIVERSAL VENTED VIAL SPIKE. IT WAS REPORTED THAT AT THE TIME OF THE INSERTION OF THE SPIKE, DROPS FROM A LEAKAGE ARE FOUND INSIDE THE VIAL CONTAINING AN ANTICANCER DRUG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851762 ↗

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-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-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-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.