ICU Medical CL3932Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709077621), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 7.5" (19 CM) APPX 1.1 ML, BIFUSE EXT SET W/CHEMOLOCK¿ PORT, CHEMOCLAVE¿, SPIROS¿, 2 CLAMPS THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT CHEMOLOCK Y CONNECTED TO AXATILIMAB & NS LINES, THEN CONNECTED TO PATIENT. AXATILIMAB INFUSION INITIATED. LEAK NOTED FROM CONNECTION AT BASE OF CHEMOLOCK TO Y TUBING, MEDICATION POOLING ON PATIENT'S BED. INFUSION STOPPED & CHEMOLOCK Y CHANGED. SPILL CLEANED UP APPROPRIATELY. INFUSION RESUMED WITH NO ISSUE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. LOST SMALL AMOUNT OF MEDICATION BUT NOT SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641493 ↗

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-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• Z-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• Z-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0340-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
• 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-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-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

…and 45 more.