ICU Medical CH-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00840619023713), received between Jul 12, 2017 and Sep 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Particulates” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934882 ↗
• MalfunctionFeb 10, 2026Particulates

  AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE BAG SPIKE WITH ADDITIVE PORT DRY SPIKE STATING THAT THERE WERE SMALL PARTICLES 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 24305578 ↗
• MalfunctionFeb 10, 2026Particulates

  AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE BAG SPIKE WITH ADDITIVE PORT DRY SPIKE STATING THAT THERE WERE SMALL PARTICLES NOTED AFTER USING SPECIFIC CH-72 VIAL SPIKES TO COMPOUND 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 24305299 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CHEMOCLAVE, ALLEGING A DEFECT THAT LED TO A LEAK DURING PATIENT USE. IT WAS STATED THAT AT THE TIME OF ADMINISTRATION, THE ICU MEDICAL SAFETY DEVICE PRESENTED PROBLEMS WITH ITS SYSTEM'S RUBBER SEAL, WHICH CAUSED A CHEMOTHERAPY LEAK. THERE WAS NO NEED TO ACTIVATE THE PROTOCOL OR USE THE SPILL KIT, AS ONLY A SINGLE DROP FORMED ON THE DEVICE AND WAS PROMPTLY IDENTIFIED AND CONTAINED BY THE NURSE. THE MEDICATION VIAL WAS RETURNED TO ITS PLASTIC PACKAGING AND SENT TO THE PHARMACY FOR REPROCESSING. IT WAS STATED THAT ALTHOUGH A SPILL INCIDENT OCCURRED, THE LEAK WAS PROMPTLY CONTAINED AND THERE WAS NO DIRECT CONTACT WITH THE PATIENT OR THE HEALTHCARE PROFESSIONAL. THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492947 ↗
• MalfunctionAug 1, 2025Particulates; Particulates

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE THE CUSTOMER REPORTED THAT AFTER CONNECTING THE SALINE SOLUTION, THE SPIKE, AND THE MACRO SET, PARTICLES WERE OBSERVED IN THE DEVICE CUP. THE NURSING TECHNICIAN REPORTED THAT SHE USES THE REPORTED PRODUCT CONNECTED TO THE BAXTER SERUM, WHICH, ACCORDING TO HER, DOES NOT HAVE WHITE PLASTIC COMPONENTS, AND THEN CONNECTS THE BRAUN SET, WHICH, ACCORDING TO HER, WHOSE NEEDLE TIP IS THICKER AND MORE POINTED. IN ADDITION, IT WAS SAID THAT, TO ENSURE PROPER FITTING AND AVOID DISCONNECTIONS, IT IS NECESSARY TO APPLY A CERTAIN AMOUNT OF FORCE TO THE CONNECTION BETWEEN THE CH-12 AND THE SET. ADDITIONALLY, IT WAS STATED THAT THE BRAUN SET ALSO DOES NOT HAVE WHITE PARTS THAT COULD JUSTIFY THE PRESENCE OF PARTICLES. THE EVENT OCCURRED DURING THE PREPARATION OF THE INFUSION, AND IT DID NOT OCCUR DURING PATIENT USE, THERE WAS NO ONE HARMED, NO DELAY IN THERAPY OR ADVERSE EVENT AS A RESULT OF THIS EVENT. THE INCIDENT DID NOT CONTRIBUTE TO A PERMANENT OR SERIOUS TEMPORARY INJURY, NOR DID IT LEAD TO OR PROLONG THE PATIENT'S HOSPITALIZATION, AND THERE WAS ALSO NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690010 ↗
• MalfunctionApr 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE THE CUSTOMER REPORTED THAT THE PAPER FILM INSIDE THE SPIKE CAME OUT INTO THE MEDICATION BAGS. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768346 ↗
• MalfunctionApr 3, 2025Particulates; Particulates

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE. IT WAS REPORTED THAT THE PAPER FILM INSIDE THE SPIKE WOULD COME OUT INTO THE MEDICATION BAGS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766771 ↗
• MalfunctionApr 2, 2025Particulates; Particulates

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE. IT WAS REPORTED THAT THE PAPER FILM INSIDE THE SPIKE WOULD COME OUT INTO THE MEDICATION BAGS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758316 ↗
• MalfunctionNov 29, 2024Particulates; Particulates

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE. IT WAS REPORTED THAT WHEN THE DEVICE WAS CONNECTED TO A SET WITH PHYSIOLOGICAL SALINE, SOME PARTICLES WERE RELEASED. THE CUSTOMER RULED OUT THE POSSIBILITY THAT THE PARTICLES CAME FROM THE SET, AS THE ISSUE OCCURRED WITH SETS FROM OTHER BRANDS AND VARIOUS LOTS. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810793 ↗
• MalfunctionNov 13, 2024Particulates; Particulates

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE THE CUSTOMER REPORTED A PARTICLE OF PLASTIC FOUND IN THE DRIP CHAMBER. IT WAS NOTED THAT THE PARTICLES WERE FOUND DURING PRIMING WITH D5W 250 ML BAG FOR PRIMING WITH NDC 0264-7510-20. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM. THIS IS THE THIRD OF 3 EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674083 ↗
• MalfunctionNov 13, 2024Particulates; Particulates

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE THE CUSTOMER REPORTED A PARTICLE OF PLASTIC FOUND IN THE DRIP CHAMBER. IT WAS NOTED THAT THE PARTICLES WERE FOUND DURING PRIMING WITH D5W 250ML BAG FOR PRIMING WITH NDC 0264-7510-20. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM. THIS IS THE SECOND OF 3 EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674053 ↗
• MalfunctionNov 13, 2024Particulates; Particulates

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE THE CUSTOMER REPORTED A PARTICLE OF PLASTIC FOUND IN THE DRIP CHAMBER. IT WAS NOTED THAT THE PARTICLES WERE FOUND DURING PRIMING WITH D5W 250ML BAG FOR PRIMING WITH NDC 0264-7510-20. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM. THIS IS THE FIRST OF 3 EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674044 ↗
• MalfunctionJul 18, 2023Disconnection; Disconnection

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE WHERE IT WAS REPORTED THAT THE SET WAS DISCONNECTED DURING PATIENT INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343921 ↗
• MalfunctionJan 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN DECEMBER, A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE HAD PARTICULATE MATTER ON THE INTRAVENOUS (IV) TUBING DRIP CHAMBER AFTER SPIKING A CH-12 BAG SPIKE CONNECTED TO A VINCRISTINE BAG WHICH WAS FOUND BY THE REGISTERED NURSE (RN) PRIOR TO PATIENT USE. THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. UPON INSPECTION BY THE ONCOLOGY PHARMACIST, IT APPEARED THAT THE SPIKE FROM THE TUBING SET SHEERED OFF A LARGE SLIVER OF PLASTIC FROM THE INNER SURFACE OF THE PORT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS TWO OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246303 ↗
• MalfunctionJan 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE HAD PARTICULATE MATTER ON THE INTRAVENOUS (IV) TUBING DRIP CHAMBER AFTER SPIKING A CH-12 BAG SPIKE CONNECTED TO A VINCRISTINE BAG WHICH WAS FOUND BY THE REGISTERED NURSE (RN) PRIOR TO PATIENT USE. THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. UPON INSPECTION BY THE ONCOLOGY PHARMACIST, IT APPEARED THAT THE SPIKE FROM THE TUBING SET SHEERED OFF A LARGE SLIVER OF PLASTIC FROM THE INNER SURFACE OF THE PORT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS ONE OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246256 ↗
• MalfunctionJul 13, 2017Obstruction of Flow; Obstruction of Flow

  POSSIBLE CH-12 "DRY SPIKE" PRODUCT FAILURE. THE DRY SPIKE APPEARS TO HAVE SHED PLASTIC FROM THE SPIKE INTO THE LINE. THE PLASTIC DID NOT REACH THE PATIENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712665 ↗
• MalfunctionJul 12, 2017Leak/Splash; Leak/Splash

  CH-12 INSERTED INTO BRAUN AND HOSPIRA IV BAGS, SPIKE EASILY PULLED OUT OF BOTH BAGS, BOTH IN THE PHARMACY COMPOUNDING PROCESS AND ALSO DURING INFUSION. FACILITY REPORTS UNPROTECTED CHEMO EXPOSURE.

  Patient problems: No Information

  MAUDE report 6708701 ↗

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-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-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-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-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-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.