ICU Medical CL3940Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709095298), received between May 4, 2025 and Jul 27, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

59 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.

Recalls naming this device

1. Sep 8, 2025Class IIOpen, Classified

   Port weld of drug transfer device may separate or break during use and potentially result in a leak.

   Z-0335-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036254 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT THAT REPORTEDLY LED TO (UNSPECIFIED) CHEMOTHERAPY SPILLAGE. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384284 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED THAT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT THAT REPORTEDLY LED TO (UNSPECIFIED) CHEMOTHERAPY SPILLAGE DURING INFUSION. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383673 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT THAT REPORTEDLY LED TO (UNSPECIFIED) CHEMOTHERAPY SPILLAGE. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383542 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BLUE SIDE PORT WAS OCCLUDED. NORMAL SALINE (NS) COULD NOT BE INSTILLED DURING FLUSHING, AND LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383300 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATING ETOPOSIDE LEAKED FROM BLUE SIDE PORT BY REGISTERED NURSE WHILE INFUSING TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383143 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A MEDWATCH REPORT # MW5171325 WAS RECEIVED ON (B)(6) 2025 STATING THAT: WITH AN ICU MEDICAL CHEMOLOCK BAG SPIKE WITH CLAVE ADDITIVE PORT, THERE WAS A REPORTED DEFECT RESULTING IN CHEMOTHERAPY LEAKAGE DURING ADMINISTRATION AT PATIENT BEDSIDE. THE ISSUE RESULTED IN CHEMOTHERAPY EXPOSURE TO BOTH PATIENT AND THE FRONTLINE HOSPITAL STAFF.

  Patient problems: Chemical Exposure

  MAUDE report 22549343 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT WHERE IT WAS REPORTED THAT UNSPECIFIED CHEMO WAS LEAKING FROM THE BLUE SIDE PORT OF THE CHEMOLOCK BAG SPIKE WITH CLAVE ADDITIVE PORT DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND POTENTIAL CHEMOTHERAPY EXPOSURE TO PATIENT/NURSE. THERE WAS NO ADVERSE EFFECT/HARM AFTER ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341453 ↗
• MalfunctionMay 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT THAT EXPERIENCED LEAKAGE DURING USE. THE REPORT STATED THAT THEY WOULD LIKE TO REPORT THAT THEY HAD ANOTHER INCIDENT WITH CHEMOTHERAPY LEAKING FROM THE BLUE SIDE PORT OF THE CHEMOLOCK BAG SPIKE WITH CLAVE. AFTER 1.5 HOURS INTO A 4-HOUR INFUSION, MOTHER OF PATIENT REPORTED CHEMOTHERAPY LEAKING FROM THE BLUE SIDE PORT. THIS CAUSED A LOT OF CONCERN WITH PATIENT'S FAMILY DUE TO SAFETY CONCERN AND HAZARD RISK THIS POSED. NURSE ONLY DOCUMENTED EVENT AND DID NOT TAKE PHOTOS. CHEMOTHERAPY PREPARATION DISCARDED IN ACCORDANCE WITH INSTITUTION CHEMO SPILL GUIDELINES. THERE WAS NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21956638 ↗

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-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-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-0334-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0339-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0333-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
• Z-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0358-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• 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-0332-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

…and 44 more.