ICU Medical CH-10-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619033859), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K081361); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A CHEMOCLAVE® BAG SPIKE, (B)(4) UNITS GENERATED A LEAK DURING PATIENT USE. THE REPORT STATES THAT THE SAMPLE WAS DEFECTIVE. NO STAFF OR PATIENTS WERE EXPOSED TO HAZARDOUS DRUGS. NO MEDICAL ATTENTION IS REQUIRED FOR EITHER STAFF OR PATIENTS. THE DRUG INVOLVED WAS CYCLOPHOSPHAMIDE AND (B)(4). DRUG DOSE, DILUENT, CONCENTRATION 750MG/D5W 500ML 750MG IN 551.75ML. THE AMOUNT SPILLED WAS APPROXIMATELY 20 ML AND NO SPILL KIT WAS USED. THE REPORT STATES THAT THE SPIKES BREAK WITH THE CYCLOPHOSPHAMIDE PRODUCT BRANDED AVYXA. AFTER THE ADDITION OF MEDICATION, THE SPIKE WAS FLUSHED. MEDICATION WAS STILL IN THE CHEMO BAG. PROPER GARBING WAS USED TO RETRIEVE OTHER MEDICATIONS IN THE SAME BAG. THE SAMPLE WAS AVAILABLE FOR EVALUATION. STERILE SAMPLES OF THE SAME LOT # WERE AVAILABLE FOR TESTING. A SAMPLE PHOTO WAS PROVIDED SHOWING THE SAMPLE AND IT SEEMS THAT IT WAS BROKEN OFF. THE CUSTOMER DOES NOT USE ICU FLUIDS, THEY USE BRAUN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081361. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3158-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1566-2021 · Mar 16, 2021 · Open, Classified
  REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications
• Z-1565-2021 · Mar 16, 2021 · Open, Classified
  REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medicatio
• Z-0701-2021 · Aug 31, 2020 · Open, Classified
  5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (1
• Z-1092-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanica
• Z-1093-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanical