ICU Medical CL3538Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709071902), received between Jul 8, 2020 and Mar 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED AN ONCOLOGY KIT ADD-ON SET W/ CHEMOLOCK ADDITIVE PORT, VENTED CAP CHEMOLOCK SPINNING SPIROS WHERE THE CUSTOMER REPORTED THAT THE SPIROS DETACHED FROM A PRIMARY LINE DURING DRUG ADMINISTRATION (TAXOL). THE REPORT ALSO STATED THAT A MINIMAL SPILL AND LEAK WAS NOTICED IMMEDIATELY. THERE WAS NO REPORT OF PATIENT HARM AS A CONSEQUENCE OF THIS EVENT.

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

  MAUDE report 24522939 ↗
• MalfunctionJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHEMOLOCK¿; SPINNING SPIROS® W/RED CAP. THE CUSTOMER STATED THAT THE LEAK SEEMED TO BE COMING FROM THE JUNCTURE OF THE SPIROS AND LINE; IT IS UNCLEAR IF THEY ARE COMING FROM THE DISTAL END OF THE SPIROS THAT CONNECTS TO THE PATIENT, OR THE PROXIMAL END THAT CONNECTS TO THE PRIMARY TUBING, BUT IT IS BELIEVED TO BE PROXIMAL END THAT CONNECTS TO THE PRIMARY TUBING. 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 19634924 ↗
• MalfunctionJul 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHEMOLOCK¿; SPINNING SPIROS® W/RED CAP THAT THE CUSTOMER REPORTED AN UNSPECIFIED CHEMOTHERAPY MEDICATION LEAKING SPECIFICALLY WITH FROM THE CHEMOLOCK BAG SPIKE COMPONENT OF THE KIT OUT FROM A MATING DEVICE. THE LEAKING OCCURRED IMMEDIATELY AFTER THE DRUG WAS ADDED TO THE BAG. THE TUBING SET UP WAS THE 5" ADD-ON-SET SPIKED INTO BAG, UNSPECIFIED TUBING SET CONNECTED TO ADD-ON-SET, AND CH-2000SC ATTACHED TO THE END OF THE TUBING. THE CHEMOTHERAPY SPILL WAS CLEANED UP PER PROTOCOL AND THERE WAS NO SPILL KIT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10244145 ↗

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-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-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• 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-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-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• Z-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

…and 44 more.