ICU Medical CL3941Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709079182), received between Aug 4, 2020 and Jun 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A ONCOLOGY KIT W/CHEMOLOCK W/CHEMOCLAVE; SPINNING SPIROS W/RED CAP WITH UNKNOWN LN AND SN: IT WAS REPORTED THAT THE REGISTERED NURSE REPORTS A ONETIME EVENT OF SYRINGE LEAKING WHEN USING CHEMOLOCK SPINNING SPIROS ON SYRINGE AND IT SEEMS THAT THE LIQUID WAS LEAKING SOMEWHERE AROUND SPIROS PIECE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443785 ↗
• MalfunctionAug 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY EVENT REPORT (MW5095102) WAS RECEIVED AND STATED "A SPINNING SPIROS, A CONTROLLED SYSTEM TRANSFER DEVICE MANUFACTURED BY ICU MEDICAL PLACED ON THE END OF TUBING AND SYRINGES FOR NEEDLESS TRANSFER TO PATIENT IV SITE, LEAKED FLUOROURACIL UPON ATTEMPTED ATTACHMENT TO PATIENT". ADDITIONALLY, IT WAS REPORTED THE SPIROS LEAKED FROM THE HOUSING ON IV PUSH INTO BD SMARTSITE. THE NURSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THE CHEMO SPILL WAS CLEANED PER FACILITY PROTOCOL AND A SPILL KIT WAS USED. IT WAS REPORTED THERE WAS UNPROTECTED CHEMO EXPOSURE, BUT NO MEDICAL INTERVENTION DONE.

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

  MAUDE report 10363625 ↗

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-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• 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-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-0359-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• Z-0337-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
• 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-0354-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
• Z-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• 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-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

…and 45 more.