ICU Medical CL3361Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709071407), received between Jan 29, 2019 and Jan 29, 2019 — 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 18, 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.

• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN ADMINISTRATION SET W/20 DROP IN-LINE CHAMBER, CHEMOLOCK W/RED CAP, SPIROS THAT RESULTED IN A CHEMO SPILL OF 15 ML OF VIDAZA. THE LEAK WAS NOTICED AT THE SPIROS CONNECTION. THE PATIENT HAD A 250 ML BAG OF NORMAL SALINE ATTACHED TO A LOW SORBING TUBING ALARIS PUMP INFUSION SET, WHICH WAS ATTACHED TO THE MINILOC SAFETY INFUSION SET BY A NEUTRON CAP AND A SPIROS CAP. THE DEVICE WAS ATTACHED TO THE PORT ABOVE THE ALARIS PUMP. THERE WAS PATIENT INVOLVEMENT AND A DELAY OF THERAPY, BUT NO REPORTED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8286889 ↗

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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• 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-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-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• 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-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• 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-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

…and 45 more.