ICU Medical CL4131Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709095779), received between Dec 14, 2023 and May 14, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3161-2026 · 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  ADDITIONAL INFORMATION FROM THE CUSTOMER WAS RECEIVED ON 05-MAY-2025 PRIMARY TUBING SET 14687-28 LOT NUMBER 14204889 CL3011 LOT 14170139. THE CHEMOTHERAPY DRUG IS TAXOTERE. NO DRUG WAS WASTED. THE B PORT BEGAN LEAKING AS SOON AS THEY PRESSED 'START' ON PUMP AFTER THE SECONDARY TUBING WAS ATTACHED. THEN THE PUMP WAS TURNED OFF AND THE PRIMARY TUBING SET WAS CHANGED OUT CL3011 TO RESOLVE ISSUES. THERE WAS A LIKELY PROXIMAL OCCLUSION. THE EVENT OCCURRED ON (B)(6) 2025 DURING USE ON PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020892 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, SPIROS¿ W/RED CAP WHERE THE CUSTOMER REPORTED THAT CHEMO DRUG, ABRAXANE, LEAKS ASSOCIATED WITH THE ICU MEDICAL TUBING. HE EVENT OCCURRED AT OUTPATIENT TREATMENT FACILITY. THE LEAKING WAS EITHER THE SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. ALL INCIDENTS INVOLVE LEAKING OR OCCLUDED/ALARMING. REPORTEDLY THE RN HUNG CHEMO, ATTACHED THE SECONDARY TUBING (FROM THE PHARMACY) TO THE CLAVE ON THE PRIMARY LINE. AS SOON AS RN OPENED THE CLAMP ON THE SECONDARY TUBING, FLUID LEAKED OUT FROM THE SPINNING SPIROS. RN WAS AT CHAIRSIDE AND IMMEDIATELY CLOSED THE CLAMPS ON THE SECONDARY TUBING AND TURNED OFF THE PLUM PUMP. THE LIQUID THAT LEAKED WAS MILKY WHITE, RESEMBLES THE ABRAXANE. THE ABRAXANE BAG, SECONDARY AND PRIMARY TUBING WERE RETURNED TO THE PHARMACY AND A NEW BAG OF ABRAXANE WAS MADE. UPON HANGING NEW BAG, THE NURSE CHANGED PRIMARY TUBING AS HIGH LIKELIHOOD OF PROXIMAL OCCLUSION. A MEDSUN/MEDWATCH REPORT # (B)(4) WAS RECEIVED AND IS ATTACHED. THE CUSTOMER REPORTED 5 SIMILAR EVENTS FROM THIS FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981512 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, SPIROS¿ W/RED CAP WHERE THE CUSTOMER REPORTED THAT THE HAZARDOUS DRUG LEAKED FROM THE TUBING DURING PATIENT USE. THE CUSTOMER STATED THAT THE NURSE HUNG THE CHEMO (CARFILZOMIB) AFTER DUAL SIGN OFF WITH SECOND NURSE. WHILE THE NURSE WAS STILL AT THE CHAIRSIDE, THEY NOTED FLUID LEAKING FROM THE SPINNING SPIROS ON THE SECONDARY TUBING THAT CAME FROM THE PHARMACY (THAT WAS CONNECTED TO THE CLAVE ON THE PRIMARY TUBING). THE SECONDARY/CHEMO LINE WAS PRIMED WITH SALINE, SO FIRST FEW DROPS THAT LEAKED OUT WOULD HAVE BEEN SALINE. THE NURSE CLOSED ALL CLAMPS AND TURNED OFF THE PLUM PUMP. BAG AND TUBING WERE RETURNED TO THE PHARMACY. PHARMACY PUT NEW SECONDARY TUBING ON THE CARFILZOMIB, DID NOT HAVE TO WASTE THE BAG. UPON HANGING THE NEW BAG, THE PLUM PUMP ALARMED "PROXIMAL OCCLUSION". THE NURSE STOPPED THE PUMP AND NOTICED THAT THE CLAVE APPEARED TO BE "PUSHED IN". THE NURSE CHANGED OUT PRIMARY TUBING LINE. THERE WAS PATIENT INVOLVEMENT HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972536 ↗
• MalfunctionApr 16, 2024Crack; Fluid/Blood Leak; Separation Problem; Crack; Fluid/Blood Leak; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, SPIROS¿ W/RED CAP. THE CUSTOMER REPORTED THAT THERE WAS POTENTIALLY AN ISSUE WITH TUBING IN THAT THE TUBING WAS EITHER FAILING OFF OR CRACKING RESULTING IN LEAKAGE. THEY STATED THAT THERE WAS AN ACTUAL INCIDENT OF LEAKING DURING PATIENT INFUSION BUT THE CAUSE WAS UNCLEAR. THE SET UP WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119972 ↗
• MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, SPIROS¿ W/RED CAP WHICH REPORTEDLY LEAKED. THE CUSTOMER STATED THAT AFTER THE ROLLER OF THE TUBING WAS RELEASED NORMALLY, THE SPIROS WOULD STOP THE FLOW OF THE FLUID, HOWEVER, THE FLUID KEPT RUNNING. THE NURSE REPORTED THAT THE MEDICATION WAS LEAKING ONTO THEIR CHEMO GLOVES. THE MEDICATION INVOLVED WAS BELATACEPT (NULOJIX). THE TUBING/SETUP WAS REPLACED USING A DIFFERENT LOT NUMBER AND THERAPY RESUMED. THE MEDICATION WAS ALSO REPLACED. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351280 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, SPIROS¿ W/RED CAP. IT WAS REPORTED THAT AS THE NURSE RELEASED THE ROLLER OF THE TUBING AND TRIED TO CONNECT TO THE PUMP, THE NURSE REALIZED THAT THE FLUID/MEDICATION WAS LEAKING ONTO THEIR CHEMO GLOVES. THE MEDICATION CAME IN CONTACT WITH THE NURSE BUT ONTO THEIR CHEMO GLOVES. BOTH NURSES WENT BACK TO WORK AS USUAL AFTER THE INCIDENT. THE TUBING/SETUP WAS REPLACED USING A DIFFERENT LOT NUMBER AND THERAPY RESUMED. THE MEDICATION WAS ALSO REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.

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

  MAUDE report 18325484 ↗

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-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-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• 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-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• Z-0361-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• 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-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• 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-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• Z-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

…and 43 more.