ICU Medical CH2000-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619023799), received between May 31, 2025 and Jul 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K070532); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A SPIROS CLOSED MALE LUER, RED CAP EXPERIENCED A SEPARATION DURING PATIENT USE. THE REPORT STATES THAT SPIROS DISCONNECTED FROM CHEMOTHERAPY. THERE WAS NO PATIENT HARM REPORTED. THE INITIAL REPORTER INDICATED THAT THE EVENT OCCURRED FOUR TIMES; HOWEVER, NO ADDITIONAL INFORMATION WAS GIVEN PERTAINING TO THE ADDITIONAL INSTANCES. A SEARCH OF THE COMPLAINT DATABASE SHOWED NO PRIOR REPORT OF THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22605356 ↗
• MalfunctionJul 1, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE IT WAS REPORTED THE PRODUCT WAS CRACKED LEADING TO CHEMOTHERAPY SPILLS. UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372730 ↗
• MalfunctionMay 31, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A SPIROS® CLOSED MALE LUER, RED CAP THAT EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THE METHOTREXATE LEAKED FROM THE SPIROS - TRIFUSE CONNECTION POINT. SPIROS WAS FULLY ATTACHED AND COULD SPIN A FULL 360. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE