ICU Medical CL3960Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00887709083271), received between Nov 14, 2024 and Sep 9, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 reports).

2 FDA recall records name this device's identifier, 2 still open.

58 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. Mar 24, 2026Class IIOpen, Classified

   Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

   Z-2210-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 27, 2022Class IIOpen, Classified

   Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

   Z-1681-2022 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693680 ↗
• MalfunctionAug 7, 2026Fluid/Blood Leak

  A reported incident involving an Oncology Kit w/60-inch (152 cm) Appx 2.2 ml, Smallbore Ext Set w/Chemo Lock Port, leakage was observed around the port component of the tubing during disconnection of a CADD pump following a 5-fluorouracil (5-FU) infusion. The event was identified upon disconnecting the infusion set. There were patient involvement and unknown harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181607 ↗
• MalfunctionApr 17, 2026Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A SET IV EXTENSION SMALLBORE 7 IN/18 CM MICROCLAVE CLEAR CLAMP ROTATING LUER PV 0.24 ML NON-DEHP WHERE THE CUSTOMER REPORTED THAT THE IV LINE WAS FOUND DISCONNECTED, WITH THE DISTAL END OF THE LINE ON THE FLOOR, THROUGH WHICH CONTINUOUS HEPARIN WAS INFUSING. THE PATIENT WAS UNABLE TO IDENTIFY WHEN THE LINE BECAME DISCONNECTED. APPROXIMATELY 10 ML OF SOLUTION WAS NOTED ON THE FLOOR. THE IV SITE WAS CHECKED, AND THE EXTENSION TUBING (LUER LOCK END) WAS OBSERVED TO HAVE BEEN DEPRESSED AND NOT RETRACTED UPON DISCONNECTION OF THE IV LINE. THE EXTENSION TUBING AND DRESSING WERE CHANGED. THE IV REMAINED PATENT, AND A NEW BAG WAS HUNG. AN ANTI-XA BLOOD DRAW WAS COLLECTED FOLLOWING THE EVENT, WHICH SHOWED A SUBTHERAPEUTIC LEVEL, DECREASING BY 0.02 POINTS FROM 0.14 TO 0.12. THIS EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912956 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  LEAKAGE WAS REPORTED ON THE FOLLOWING DEVICE: 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. THE CUSTOMER STATED THAT AN UNSPECIFIED FLUID WAS POOLING/LEAKING FROM WHERE THE TUBING MEETS THE CHEMOLOCK PORT AND IS THEN POURING OVER THE SIDE. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348329 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 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 WHERE A LEAK WAS REPORTED AT THE BASE OF THE CHEMOLOCK PORT. THIS HAPPENED TWO TIMES. THE MEDICATION USED WAS FLUOROURACIL. THE ICU TUBING SET IS ATTACHED TO THE CADD PUMP TUBING PRIOR TO MEDICATION BEING INJECTED INTO THE CADD PUMP. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304474 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PUMP CASSETTE TUBING WHERE THE REPORTER STATED THAT "THE CASSETTE TUBING LEAKED OUT OF THE BLUE PORT USED TO FILL THE CASSETTES. THIS WAS THE 1ST INCIDENT THAT THEY HAD ISSUES WITH CHEMOTHERAPY LEAKING AT THE PORT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM. THERE WAS EXPOSURE TO HAZARDOUS DRUG AND THERE WAS A SLIGHT DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059708 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED INVOLVING AN 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. THE CUSTOMER REPORTED THAT THE CASSETTE TUBING LEAKED (FROM WHAT APPEARED TO BE FROM THE BLUE PORT USED TO FILL THE CASSETTES ) WHILE THE PUMP WAS ATTACHED TO THE PATIENT MIDWAY THROUGH THEIR 46HRS THERAPY. THE CUSTOMER STATED THAT IT THERE WAS EXPOSURE TO THE UNSPECIFIED CHEMOTHERAPY MEDICATION; NO INTERVENTION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT, A SLIGHT DELAY IN THERAPY, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039574 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN 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 WHERE THE CUSTOMER REPORTED THAT THE CHEMOTHERAPY MEDICATION (5FU) WAS LEAKING FROM TUBING INSIDE THE POUCH. THE PATIENT NOTED THAT THE SAW DRIED WHITE RESIDUE ON TUBING AND BAG. THEY HAD ALREADY POWERED THE PUMP OFF AND WAS ADVISED TO CLOSE THE CLAMPS. THE CHEMO SPILL PRECAUTIONS WERE DISCUSSED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947549 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNKNOWN DATE WITH REGARDS TO 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 WHERE THE REPORTER STATED THAT "THEY HAD MULTIPLE COMPLAINTS RELATED TO LEAKING FROM THE CL PORT ON THE CL3960". ABOUT SEVEN (7) SAMPLES WERE REPORTED TO BE AFFECTED. THERE WERE UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900574 ↗
• MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNKNOW DATE REGARDING AN ICU MEDICAL AMBULATORY PUMP TUBING - 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 WHERE IT WAS REPORTED THAT OVER THE LAST COUPLE OF WEEKS, THE DEVICE CONNECTED TO THEIR PATIENT HAS BEEN LEAKING AND GETTING ON PATIENT'S SKIN. IT APPEARS IT MAY BE THE PORTION AT THE BOTTOM JUST ABOVE WHERE IT CONNECTS TO THE PATIENT'S PORT LINE OR THE BLUE PORT. THEY ALSO REPORTED THAT THIS HAPPENED WITH BOTH OF THEIR PUMPS CONTINUOUS AMBULATORY DRUG DELIVERY (CADD) LEGACY AND CADD SOLIS. THEY REPORTED TWO (2) INCIDENTS WITH TWO PATIENTS WHO HAD CHEMOTHERAPY PUMPS LEAK. AS THEY STATED, THIS IS CREATING HAVOC WITH PATIENT CARE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. THERE WAS DELAY IN ALL TREATMENT FOR PATIENTS AS THE PUMP STOPPED, PATIENTS HAD TO COME INTO INFUSION CENTER, AND DRUG HAD TO BE RE-MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739434 ↗
• MalfunctionJul 14, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 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. THE REPORTER STATED THAT WHEN THEY FIRST STARTED TO USE THIS TUBING, THE CONNECTION WAS NOT STAYING CLOSED. THEY FOUND IT WAS ABLE TO BE DETACHED, AND THEY HAD SEVERAL CASSETTES LEAK. THEY DON'T THINK IT IS FROM THE ACTUAL CASSETTE, AS THEY HAVE HAD THE SAME ISSUE WITH DIFFERENT SIZE CASSETTES. THE PATIENTS DID HAVE POTENTIAL EXPOSURE TO HAZARDOUS MEDICATIONS IN THEIR HOMES. ALSO, IT WOULD APPEAR THAT PATIENTS DID NOT RECEIVE THEIR ENTIRE DOSE OF MEDICATION. THE 5FU WAS IN THE BAG. ALL LEAKS HAVE OCCURRED ONCE THE PATIENT LEFT THE FACILITY. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO ADVERSE EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 22501497 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A AN 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 THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT LEAKING FROM CHEMOLOCK BONDED PORT. THE EVENT DATE WAS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481077 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 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 THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT LEAKING OCCURRING FROM PIGTAIL CONNECTION FROM CADD CASSETTE AND PROXIMAL END OF CL3960. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480602 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 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. THE REPORTER STATED THAT A PATIENT HAD 5FU LEAKED ON THEM. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 22473371 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN 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 WHERE IT WAS REPORTED THERE WERE 4 OCCASIONS OF LEAKING COMING FROM THE BONDED CHEMOLOCK PORT ON THE DRUG ADDITIVE PORT OF THIS SET. 5FU WAS NEEDED TO BE DISCARDED AND REMADE CAUSING DELAY IN PATIENT CARE AND ADDITIONAL STAFF TIME AND RESOURCES IN MAKING NEW MEDICATIONS. IT WAS STATED THAT THE EVENTS OCCURRED DURING COMPOUNDING AND ALTHOUGH IT DID COME IN CONTACT WITH THE TECHNICIAN'S HANDS; THE TECHNICIAN WAS DOUBLE GLOVED, AND NO UNPROTECTED EXPOSURE REPORTED. HOWEVER, THERE WAS AN EVENT THAT OCCURRED ON A PATIENT AT HOME. THE PATIENT WAS EXPOSED TO FLUOROURACIL ON THEIR SKIN AND CLOTHES. THE PATIENT RETURNED TO THE HEALTHCARE FACILITY AND WAS DE-ACCESSED. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE EVENT OCCURRED WHILE MIXING AND QUESTIONABLE LEAK AT HOME WITH A PATIENT. NO HARM REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 22359155 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 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. IT WAS REPORTED THAT THERE WAS LEAKING OBSERVED WHERE IT IS CONNECTED TO THE CHEMOLOCK PORT. TWO INCIDENTS HAPPENED WHEN THE PATIENTS WERE HOME WITH THEIR PUMPS. THIS REPORT CAPTURES THE FIRST OF TWO EVENTS. THERE WAS UNINTENDED EXPOSURE TO CHEMOTHERAPY. THE MEDICATION WAS LEAKING FROM THE TUBING, CAUSING FOR CHEMOTHERAPY TO BE OUTSIDE THE CLOSED SYSTEM. TWO INCIDENTS HAPPENED WITH ONE PATIENT - THE TUBING WAS LEAKING, PUMP REPLACED, THEN THE NEW TUBING LEAKED. THE LAST INCIDENT HAPPENED FOR ANOTHER PATIENT WHERE THE TUBING WAS LEAKING AT HOME. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302463 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 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. IT WAS REPORTED THAT THERE WAS LEAKING OBSERVED WHERE IT IS CONNECTED TO THE CHEMOLOCK PORT. TWO INCIDENTS HAPPENED WHEN THE PATIENTS WERE HOME WITH THEIR PUMPS. THIS REPORT CAPTURES THE SECOND OF TWO EVENTS. THERE WAS UNINTENDED EXPOSURE TO CHEMOTHERAPY. THE MEDICATION WAS LEAKING FROM THE TUBING, CAUSING FOR CHEMOTHERAPY TO BE OUTSIDE THE CLOSED SYSTEM. TWO INCIDENTS HAPPENED WITH ONE PATIENT - THE TUBING WAS LEAKING, PUMP REPLACED, THEN THE NEW TUBING LEAKED. THE LAST INCIDENT HAPPENED FOR ANOTHER PATIENT WHERE THE TUBING WAS LEAKING AT HOME. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302079 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 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 WHERE IT WAS REPORTED THE TUBING SET LEAKED AT THE CONNECTION OF THE CHEMOLOCK PORT. THE INCIDENT OCCURRED WHILE COMPOUNDING IN THE PHARMACY HOOD WHERE THERE WAS UNINTENDED EXPOSURE TO CHEMOTHERAPY. THE MEDICATION WAS LEAKING FROM THE TUBING, CAUSING FOR CHEMOTHERAPY TO BE OUTSIDE THE CLOSED SYSTEM. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 22297859 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE SAMPLE IS NO LONGER AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657947 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING AN 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 THAT EXPERIENCED LEAKAGE. THIS IS REPORT 3 OF 3. THE REPORTER STATED THAT THEY ENCOUNTERED LEAKING FROM THEIR CADD ONCOLOGY KIT. THE EVENT DATE OCCURRED ON (B)(6) 2025. STATUS WAS WHILE IN USE IN PATIENT. THE SAMPLES ARE AVAILABLE FOR EVALUATION. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657934 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE SAMPLE IS NO LONGER AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657698 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN 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 WAS FOUND TO HAVE GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT ANOTHER LEAKING HAPPENED. THE TUBING WAS INTACT AND NOT LEAKING AT THE TIME OF PREPARATION. WHEN THE PATIENT RETURNED TO THE INFUSION CENTER, THE PATIENT REPORTED LEAKING AND HAVING THE TAPE THE BLUE PORT TO STOP LEAKING. THERE WAS NO HARM BUT EXPOSURE AND NO DELAY IN THERAPY. THE MEDICATION INVOLVED IS FLUOROURACIL NDC 25021-0215-98.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529205 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE(S) AND INVOLVED AN 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. THE CUSTOMER REPORTED THAT THEY HAD HAD 3 INCIDENTS IN THE LAST 2 WEEKS THAT INVOLVED THEIR PATIENTS USING ICU CADD SOLIS PUMPS WITH 250ML CADD CASSETTES WITH CL3960 ONCOLOGY KIT EXTENSION TUBING HAVING LEAKED AT THE BLUE PORT AND CONNECTION SITE BETWEEN THE CADD PUMP TUBING AND THE CL3960 TUBING. IN ALL THREE CASES DRUG HAD LEAKED IN THE CADD POUCH AND HAD VISIBLE SIGNS OF DRIED DRUG POWDER ON THE CL3960 TUBING AND NOT IN THE CADD CASSETTE. THERE WAS NO PATIENT HARM AND THERE IS EXPOSURE TO CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365731 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE COMPLAINT/EVENT INVOLVED A 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. THE TUBING REPORTEDLY FELL OUT OF THE ADAPTOR THAT CONNECTS TO THE BLUE CONNECTOR. THERE WAS LEAKAGE OF 5-FLUOROURACIL (5FU) WITH NDC NUMBER (B)(4). A WHITE POWDERY SUBSTANCE WAS OBSERVED ALL OVER THE INFUSION BAG. THE PATIENT WAS NOT AWARE THAT THERE WAS LEAKING UNTIL THE THEY WENT BACK TO THE CLINIC FOR PUMP DISCONNECTION, WHICH WAS ALMOST 47 HOURS SINCE THE START OF THE INFUSION. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799623 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED 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 WHERE THE CUSTOMER REPORTED A LEAK FROM TUBING. IT WAS NOTED THAT ABOUT 23 HOURS AFTER STARTING THE PUMP, THE PATIENT NOTICED THAT IT WAS LEAKING IN THE TUBING AND STOPPED THE PUMP. THE MEDICATION THAT WAS LEAKING WAS A 5-FLUOROURACIL WITH NDC NUMBER 63323-0117-61. IT WAS ALSO NOTED THAT THE TUBING HAD FALLEN OUT OF THE PIECE THAT CONNECTS TO THE BLUE CONNECTOR. IT WAS NOTED THAT THERE WERE 3 LEAKS WITH THE TUBING WHEN THE PATIENT WAS AT HOME DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN HUMAN HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685588 ↗

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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0337-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0352-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• 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-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-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-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• 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-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

…and 43 more.