ICU Medical CH-72Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840619053192), received between Apr 14, 2021 and Feb 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Particulates” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Particulates

  AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE VENTED VIAL SPIKE STATING THAT THERE WAS A SMALL PARTICLE NOTED AFTER USING SPECIFIC CH-72 VIAL SPIKES TO COMPOUNDING BUSULFAN AND INFUSING IT THROUGH THE CH-12 ADAPTER INTO THE FINAL BAG. NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305004 ↗
• MalfunctionFeb 10, 2026Particulates

  AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE VENTED VIAL SPIKE STATING THAT THERE WAS A SMALL PARTICLES NOTED AFTER USING SPECIFIC CH-72 VIAL SPIKES TO COMPOUND BUSULFAN AND INFUSE IT THROUGH THE CH-12 ADAPTER INTO THE FINAL BAG. NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304850 ↗
• MalfunctionFeb 4, 2026Particulates

  AFTER USING A CHEMOCLAVE¿ VENTED VIAL SPIKE, 13MM FOR COMPOUNDING BULSULFAN, SMALL PARTICLES WERE REPORTED. THE SOLUTION WAS INFUSED THROUGH THE CH-12 ADAPTER INTO THE FINAL BAG. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263718 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CHEMOCLAVE® VENTED VIAL SPIKE, 13MM GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT "RECONSTITUTING A PEMBROLIZUMAB, WHEN TURNED UPSIDE DOWN TO PUT PEMBRO LIQUID INTO SYRINGE THE PEMBRO SPIKE LEAKED ALL OVER STAFF MEMBERS HAND." IT WAS UNKNOWN IF THE SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478257 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A FLOW OF CMR DRUG (CARCINOGENIC, MUTAGENIC AND TOXIC TO REPRODUCTION SUBSTANCES) ON THE GLOVES. THERE WERE NO INJURIES FOR A PATIENT OR OPERATOR AND NO NEED FOR MEDICAL INTERVENTION. THERE WAS A SPILL OF DANGEROUS PRODUCT, CLEANED AS PER PROTOCOL, HOWEVER NO SPECIFIC KIT WAS REPORTED TO BE USED. THE OPERATOR WAS PROTECTED WITH PROPER PPE (GLOVES AND TYVEK PROTECTION EQUIPMENT). THERE WERE NO UNPROTECTED EXPOSURES (DERMAL OR OTHER KIND OF EXPOSURE).

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

  MAUDE report 11665007 ↗

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-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
• 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