ICU Medical CL-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709121195), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVING A CHEMOCLAVE¿ BAG SPIKE W/PORT, DRY SPIKE LN 011-CH12 EXPERIENCED LEAKAGE. THE INITIAL REPORTER STATED THAT THE SET HAD BROKEN, AND THE PIECE WAS KEPT IN THE SYRINGE, WHEN THEY WENT TO WASH THE LINE WITH SALINE SOLUTION BY INTRODUCING IT THROUGH THE CH-12. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, IT WAS CONTAMINATED OR CONTAINED SOME BIOHAZARD OR CHEMOTHERAPEUTIC AGENT, AND IT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE PRODUCT STATUS WAS DURING USE, FOR 1 HOUR, WITH A PATIENT. THE AFFECTED SAMPLE CH-12 WAS DISCARDED SINCE IT CAME IN CONTACT WITH A POTENTIALLY TOXIC INVESTIGATIONAL (CLINICAL TRIAL) MEDICATION. AN INTERLEUKIN-2 (IL-2) VARIANT PROTEIN MEDICATION WAS USED WITH THE PRODUCT. THREE PICTURES WERE PROVIDED SHOWING THE PRODUCT. THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS DELAY IN THERAPY. HOWEVER, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018328 ↗

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-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• 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-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-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-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-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.