ICU Medical CL4130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709095533), received between Jul 23, 2021 and May 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, CHEMOLOCK¿ W/RED CAP WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) NOTICED A LEAK AT THE CONNECTION BETWEEN THE SECONDARY TUBING AND THE CLOSED-SYSTEM TRANSFER DEVICE (THE CLEAR PLASTIC PIECE THAT CONNECTS THE FLEXIBLE TUBING AND THE BLUE CHEMOLOCK PIECE OF THE SECONDARY TUBING). THE DRUG INVOLVED IS FLUDARABINE 78.75MG IN NS 107ML. 15-20CCS WERE ESTIMATED SPILLED. A SPILL KIT WAS USED. PATIENTS OR STAFF DID NOT NEED MEDICAL ATTENTION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061198 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, CHEMOLOCK¿ W/RED CAP WHERE IT WAS REPORTED THAT WHEN BAG OF CHEMOTHERAPY WAS HUNG AT THE PATIENT'S CHAIRSIDE IT LEAKED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THEY HAD 3 INCIDENCES OF LEAKING AND HAVE CHECKED THE BAGS AND THE INTEGRITY SEEMS FINE. THIS REPORT 2 OF 3 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929251 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, CHEMOLOCK¿ W/RED CAP WHERE IT WAS REPORTED THAT WHEN BAG OF CHEMOTHERAPY WAS HUNG AT THE PATIENT'S CHAIRSIDE IT LEAKED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THEY HAD 3 INCIDENCES OF LEAKING AND HAVE CHECKED THE BAGS AND THE INTEGRITY SEEMS FINE. THIS REPORT 1 OF 3 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929188 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ ADDITIVE PORT, CHEMOLOCK¿ W/RED CAP WHERE IT WAS REPORTED THAT WHEN BAG OF CHEMOTHERAPY WAS HUNG AT THE PATIENT'S CHAIRSIDE IT LEAKED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THEY HAD 3 INCIDENCES OF LEAKING AND HAVE CHECKED THE BAGS AND THE INTEGRITY SEEMS FINE. THIS REPORT 3 OF 3 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20928962 ↗
• MalfunctionJul 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BIG SPILL OF ADRIAMYCIN OCCURRED DURING AN INFUSION USING A CHEMOLOCK TRANSFER DEVICE. THE REPORTER STATED, THE SPIKE DISLODGED FROM THE BAG. ONCE THE DEVICE IS SPIKED INTO THE FLUID BAG AND ROTATED ON THE LINE WHERE THE CIRCLE IS BELOW, THE FLUID STARTS LEAKING OUT. THE CHEMO SPILL WAS REPORTEDLY CLEANED PER PROTOCOL AND A SPILL KIT WAS USED. THERE WAS UNKNOWN CHEMOTHERAPY EXPOSURE REPORTED. THERE WAS NO REPORT OF HOLES, CUTS OR TEARS NOTICED ON THE PRODUCT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218554 ↗
• MalfunctionJul 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BIG SPILL OF ADRIAMYCIN OCCURRED DURING AN INFUSION USING A CHEMOLOCK TRANSFER DEVICE. IT WAS REPORTED THAT THE SPIKE DISLODGED FROM THE BAG. ONCE THE DEVICE IS SPIKED INTO THE FLUID BAG AND ROTATED ON THE LINE WHERE THE CIRCLE IS BELOW, THE FLUID STARTS LEAKING OUT. THE REPORTER STATED WHILE TRYING TO UNCLIP THE BLUE PART TO PRIME AND ADMINISTER THE DRUG THE SPIKE COMPLETELY CAME OUT OF THE IV. THERE WAS A REPORTED 80 MLS OF ADRIAMYCIN TO SPILL. THE HEALTHCARE PROVIDER WAS REPORTED TO BE WEARING FULL CHEMOTHERAPY ADMINISTRATION PROTECTIVE EQUIPMENT. A SMALL AMOUNT WAS REPORTED TO HAVE SPILLED ONTO THE HEALTHCARE PROVIDER'S SHOES. THE HEALTHCARE PROVIDER WAS REPORTED TO HAVE CHANGED INTO CLEAN SHOES. THE CHEMO SPILL WAS REPORTEDLY CLEANED PER PROTOCOL AND A SPILL KIT WAS USED. THE TUBING WAS SAID TO BE REPLACED WITH THE BAG OF CHEMOTHERAPY THEN THE TUBING AND BAG WERE DISPOSED OF INTO A CHEMOTHERAPY BIN. THE PHARMACY PREPARED ANOTHER BAG OF CHEMOTHERAPY. THERE WAS NO REPORT OF HOLES, CUTS OR TEARS NOTICED ON THE PRODUCT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

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

  MAUDE report 12218143 ↗

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-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• 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-0360-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
• Z-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• 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
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• 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-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• 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
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

…and 43 more.