ICU Medical CL3931Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709077201), received between Jan 27, 2020 and Sep 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918483 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP, CLAMP. IT WAS REPORTED THAT ON THE PATIENT¿S 5TH, AND LAST, DAY OF R-EPOCH THE DEVICE WAS LEAKING FROM THE SPIROS END ONTO THE PATIENT'S BED. THE CHEMOTHERAPY INFUSING WAS DOXORUBICIN, ETOPOSIDE AND VINCRISTINE. THE PATIENT, AND AREA, WERE CLEANED UP PER THE CUSTOMER'S PROTOCOL. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE SPIROS WAS CONNECTED TO THE BAXTER ONELINK ON PATIENT'S PORTAL. THERAPY WAS ENDED; THERE WAS NO BLOOD LOSS OR BLEED BACK. NO HOLES WERE NOTED ON THE DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO ADVERSE EVENT OR HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751932 ↗
• MalfunctionFeb 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP, CLAMP THAT AT 7:30-7:45AM LEAKED BUSULFAN ON THE PATIENT. IT WAS REPORTED THAT THE PATIENT CALLED THE NURSE AND IT WAS FOUND THAT THE PATIENT WAS COVERED WITH CHEMO, BUT NO VISIBLE AFFECTS WERE OBSERVED. THE PATIENT'S CHEMO TREATMENT WAS DISCONTINUED FOR THE DAY. A SPILL KIT WAS USED FOR CLEAN UP. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 11333737 ↗
• MalfunctionAug 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT WAS RECEIVED THAT STATED ¿THE RN CONNECTED A CHEMOTHERAPY LINE TO A PATIENT, AND LINE WAS FLUSHED MANUALLY. RN TIGHTENED ALL THE CONNECTIONS AND THE LINE WAS DOUBLE CHECKED PRIOR TO STARTING CHEMOTHERAPY. IMMEDIATELY UPON STARTING THE CHEMOTHERAPY, THE PATIENT REPORTED FEELING MOISTURE. THERE WAS A LEAK ON THE IV MICROCLAVE CLEAR WITH CHEMOLOCK CONNECTOR.¿ THE EVENT OCCURRED ON AN UNSPECIFIED DAY IN (B)(6) 2020 AND HAPPENED IN THE PATIENT¿S ROOM OF THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10454799 ↗
• MalfunctionJun 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP LEAKED CHEMOTHERAPY. IT WAS FURTHER DESCRIBED THAT AFTER CHEMOTHERAPY FINISHED, THERE WAS A WET LIQUID NOTICED AROUND THE CHEMOLOCK PORT FROM THE BACKSIDE OF PORT. THIS OCCURRED DURING PATIENT USE AFTER AN HOUR AFTER THE START. THE PATIENT WAS WASHED AND THE BED WAS CHANGED. THE CHEMO SPILL WAS CLEANED UP AS PER FACILITY PROTOCOL. THERE WAS A MINIMAL LOSS, THAT WAS FOUND STRAIGHT AWAY AND THE EXTENSION SET WAS REPLACED. THE TUBING WAS SET UP WITH STANDARD SETUP SALINE LINE AND CHEMO LINE IN THE EXTENSION SET IN RESPECTIVE PORTS, THERE WAS NO BLOOD LOSS OR BLEED BACK. THERE WAS NO ADVERSE EVENT AND NO HARM AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146169 ↗
• MalfunctionJan 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP, CLAMP, THAT WHEN ADMINISTERING MELPHALAN TO A HOSPITAL INPATIENT, VIA AN UNSPECIFIED PUMP, LEAKING WAS DISCOVERED COMING FROM THE BACKSIDE OF THE CHEMOLOCK PORT WHERE IT IS BONDED ON THE Y-SITE OF THE EXTENSION SET. THE TUBING SET UP WAS THE LINE WAS PRIMED WITH SALINE FROM THE RESCUE LINE, AND THEN ATTACHED TO THE PATIENT. THE CLINICIAN DID NOT PRIME AT THE CHEMOLOCK PORT. THE EXTENSION SET HAD BEEN IN USE FOR 1 HOUR AND THE LEAK WAS NOTED WHEN THE CLINICIAN CHECKED ON THE PATIENT AT 8AM. THERE WAS ONLY A SMALL AMOUNT OF LEAKAGE BEFORE IT WAS CAUGHT. IT WAS REPORTED THAT THE CHEMOTHERAPY MEDICATION CAME IN CONTACT WITH THE PATIENT AND THE CLINICIAN. THE PATIENT WAS WASHED WITH SOAP AND WATER AND THE SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE EXTENSION SET WAS REPLACED BUT THE DRUG WAS NOT REPLACED SINCE THERE WAS 100-125ML LEFT OF A 1000ML INFUSION WHEN THE LEAK OCCURRED. AS THE LEAK WAS NOT FROM THE BAG SIDE (THAT CHEMOLOCK ATTACHMENT WAS PATENT) THE CHEMOLOCK EXTENSION SET WAS REPLACED AND THE REMAINDER OF THE DRUG WAS INFUSED WITHOUT INCIDENT. THERE WERE NO DEFEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9634266 ↗

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-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-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• 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-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0362-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

…and 45 more.