ICU Medical CL-13-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709079045), received between Jul 13, 2023 and Feb 2, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Particulates” (6 reports).

60 other recalls cover devices cleared under the same FDA submission (K131549); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Chemical Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED THE FOLLOWING MEDICAL DEVICE: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, 10 UNITS. WHITE FILM WAS REPORTED ON THE TUBING DURING PREPARATION TO TUBE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT, NO HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240240 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE SIXTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315499 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE THIRD OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315498 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE FIFTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315496 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE FOURTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315495 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE FIRST OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315492 ↗
• MalfunctionJul 13, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. IT WAS REPORTED THAT THERE WAS A WHITE, PARTICULATE SUBSTANCE IN THE TUBING. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT HAPPED UPON REMOVAL FROM ORIGINAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND NO DELAY IN THERAPY. THIS IS THE SECOND OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315488 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131549. 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-2210-2026 · Mar 24, 2026 · Open, Classified
  Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
• Z-0331-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• Z-0365-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
• Z-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• Z-0338-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0359-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0352-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80

…and 45 more.