ICU Medical CH3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840619023966), received between Aug 3, 2020 and Apr 24, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

8 other recalls cover devices cleared under the same FDA submission (K173477); 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 ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026

  DURING HAZARDOUS DRUG COMPOUNDING, AN ICU MEDICAL CHEMO CLAVE SPIROS DEVICE BECAME UNLATCHED AFTER CONNECTION TO THE IV BAG, ALLOWING APPROXIMATELY 5 ML OF CHEMOTHERAPY SOLUTION TO SPILL ONTO THE HOOD WORK SURFACE. THE SYRINGE WAS PROMPTLY RE-SECURED TO STOP THE FLOW, THE DEVICE WAS SAFELY DISCONNECTED, AND THE SPILL WAS CLEANED AND DECONTAMINATED PER PROTOCOL. NO EXPOSURE OUTSIDE THE HOOD OCCURRED. THIS HAS BEEN AN ONGOING PROBLEM REPORTED BY THE PHARMACY TO THE ICU MEDICAL TEAM. DEVICES IDENTIFIED: (3 DEVICES). ICU MEDICAL: 30" (76CM) APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMOCLAVE DRIP CHAMBER, SPIROS. WITH RED CAP, BAG HANGER. (B)(4). REF CH3011, (B)(4). (10) MULTIPLE LOT NUMBERS. ICU MEDICAL CHEMOCLAVE UNIVERSAL VENTED VIAL SPIKE. REF: CH-70 (B)(4), (10) MULTIPLE LOT NUMBERS. ICU MEDICAL: SPIROS CLOSED MALE LUER W/RED CAP, 10 UNITS. REF CH2000SC-10 (B)(4), (10) MULTIPLE LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980419 ↗
• MalfunctionJul 21, 2025No Flow; No Flow

  DURING TESTING, A USED 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER WAS FOUND TO BE OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560578 ↗
• MalfunctionJul 21, 2025No Flow; No Flow

  IT WAS REPORTED, ON AN UNKNOWN DATE, THAT A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER WAS FOUND TO BE OCCLUDED DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE DRUG WAS PULLED INTO A SYRINGE FROM A VIAL WITH SPIROS (CH2000SC-10), THEN CONNECTED TO THE CH3011 CIRCLE PRIMING PORT FOR INFUSION INTO THE BAG. THE FLUID PATH WOULD NOT ALLOW ANY INFUSION FROM THE SYRINGE + SPIROS INTO THE BAG. WHEN THE SYRINGE + SPIROS WAS DETACHED, THEIR CIRCLE PRIMING CLAVE DID NOT HAVE ¿STICK DOWN¿. THE PHARM TECH REMOVED THE SPIROS AND TESTED IF THEY COULD INFUSE USING ONLY A SYRINGE, AND IT WORKED. THIS ISSUE WAS VERY CONSISTENT, AT LEAST ONE, IF NOT MULTIPLE TIMES A DAY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560459 ↗
• MalfunctionJun 12, 2025Disconnection; Disconnection

  THE COMPLAINT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER. IT WAS REPORTED THAT THERE ARE INCOMPLETE, EASILY REVERSIBLE CONNECTIONS. THE LUER LOCK GASKET OR BALL IS NOT SPRINGING BACK TO RESEAL AS IT SHOULD, RESULTING IN THE VALVE TO STAY OPEN. THE SPIROS WILL CLICK AS IT NORMALLY DOES WHEN IT IS LOCKED BUT THEN WILL EASILY DISCONNECT AND FALL OFF THE SYRINGE. THERE WAS NO PATIENT HARM BUT POTENTIAL SPILLAGE OF HAZARDOUS MATERIALS TO THEIR TECHNICIAN STAFF POSES DIRECT EXPOSURE AND HARM. THERE WAS NO DELAY IN THERAPY BUT, BUT DRUG WASTED FROM BAGS LEAKING. LEAKING OUT OF THE UNSEALED VALVE. THE EVENT OCCURRED ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194560 ↗
• MalfunctionJun 11, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT WHICH OCCURRED ON AN UNSPECIFIED DATE, INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER, WHERE THE LUER LOCK GASKET OR BALL IS NOT SPRINGING BACK TO RESEAL AS IT SHOULD, RESULTING IN THE VALVE TO STAY OPEN AND ARE INCOMPLETE, EASILY REVERSIBLE CONNECTIONS. THEY STATED THAT THE SPIROS WILL CLICK AS IT NORMALLY DOES WHEN IT IS LOCKED BUT THEN WILL EASILY DISCONNECT AND FALL OFF THE SYRINGE. THEY STATED THAT DRUG WASTED FROM THE BAGS, LEAKING OUT OF THE UNSEALED VALVE. THERE WAS NO PATIENT HARM AND UNKNOWN DELAY IN THERAPY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190729 ↗
• MalfunctionJun 11, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT WHICH OCCURRED ON AN UNSPECIFIED DATE, INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER, WHERE THE LUER LOCK GASKET OR BALL IS NOT SPRINGING BACK TO RESEAL AS IT SHOULD, RESULTING IN THE VALVE TO STAY OPEN AND ARE INCOMPLETE, EASILY REVERSIBLE CONNECTIONS. THEY STATED THAT THE SPIROS WILL CLICK AS IT NORMALLY DOES WHEN IT IS LOCKED BUT THEN WILL EASILY DISCONNECT AND FALL OFF THE SYRINGE. THEY STATED THAT DRUG WASTED FROM THE BAGS, LEAKING OUT OF THE UNSEALED VALVE. THERE WAS NO PATIENT HARM AND UNKNOWN DELAY IN THERAPY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190720 ↗
• MalfunctionJun 10, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER ON AN UNSPECIFIED DATE, WHERE THE LUER LOCK GASKET OR BALL IS NOT SPRINGING BACK TO RESEAL AS IT SHOULD, RESULTING IN THE VALVE TO STAY OPEN AND ARE INCOMPLETE, EASILY REVERSIBLE CONNECTIONS. THEY STATED THAT THE SPIROS WILL CLICK AS IT NORMALLY DOES WHEN IT IS LOCKED BUT THEN WILL EASILY DISCONNECT AND FALL OFF THE SYRINGE. THEY STATED THAT DRUG WASTED FROM THE BAGS AS IT WAS LEAKING OUT OF THE UNSEALED VALVE. THERE WAS NO PATIENT HARM AND UNKNOWN DELAY IN THERAPY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179504 ↗
• MalfunctionJun 10, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER, WHERE THE LUER LOCK GASKET OR BALL IS NOT SPRINGING BACK TO RESEAL AS IT SHOULD, RESULTING IN THE VALVE TO STAY OPEN AND ARE INCOMPLETE, EASILY REVERSIBLE CONNECTIONS. THEY STATED THAT THE SPIROS WILL CLICK AS IT NORMALLY DOES WHEN IT IS LOCKED BUT THEN WILL EASILY DISCONNECT AND FALL OFF THE SYRINGE. THEY STATED THAT DRUG WASTED FROM THE BAGS, LEAKING OUT OF THE UNSEALED VALVE. THERE WAS NO PATIENT HARM AND UNKNOWN DELAY IN THERAPY AS A RESULT OF THIS EVENT. THE EVENT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179171 ↗
• MalfunctionAug 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER WHERE THE CUSTOMER REPORTED THAT A PATIENT WAS PLACED IN THE SECONDARY SET THROUGH WHICH ONLY GLUCOSE SOLUTION 10 % PASSED, IT WAS OBSERVED GROWTH OF BLACK BALLS WITH HAIRS, SUSPICIOUS OF SOME MICROORGANISM, 48 HOURS AFTER USE. THEY ARE LOOKING FOR DISCARD THAT IT IS NOT A PROBLEM OF THE SET. THE GLUCOSE SOLUTION WAS ADMINISTERED FOR 40 HOURS, AND THE PROBLEM WAS NOTICED WHEN HANDLING IT AT THE TIME OF GOING TO USE THE SET. THE PRODUCT STATUS DURING THE EVENT WAS DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO ONE WAS HARMED IN THE EVENT. ALSO, THERE WAS NO ADVERSE EVENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991929 ↗
• MalfunctionAug 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER THAT LEAKS AN UNSPECIFIED HAZARDOUS DRUG FROM THE TUBING OUT OF THE SPIROS AFTER THEY HAVE PRIMED THE LINE WITH FLUID. THIS RESULTS IN EXPOSURE TO HAZARDOUS MATERIAL AND WASTED PRODUCT TO REMAKE THE DOSE. THE SOLUTION INFUSED WAS MADE BY B. BRAUN MEDICAL. THE SOLUTION BAG WAS SPIKED WITH TUBING AT THE PORT, THEN THE TUBING WAS PRIMED WITH THE NORMAL SALINE SOLUTION PRIOR TO ADDITION OF THE DRUG. THE LEAK IS TYPICALLY NOT NOTICED UNTIL AFTER COMPOUNDING WITH THE UNSPECIFIED MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT CAPTURES THE THIRD OF THREE EVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 10358938 ↗
• MalfunctionAug 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER THAT LEAKS AN UNSPECIFIED HAZARDOUS DRUG FROM THE TUBING OUT OF THE SPIROS AFTER THEY HAVE PRIMED THE LINE WITH FLUID. THIS RESULTS IN EXPOSURE TO HAZARDOUS MATERIAL AND WASTED PRODUCT TO REMAKE THE DOSE.THE SOLUTION INFUSED WAS MADE BY B. BRAUN MEDICAL. THE SOLUTION BAG WAS SPIKED WITH TUBING AT THE PORT, THEN THE TUBING WAS PRIMED WITH THE NORMAL SALINE SOLUTION PRIOR TO ADDITION OF THE DRUG. THE LEAK IS TYPICALLY NOT NOTICED UNTIL AFTER COMPOUNDING WITH THE UNSPECIFIED MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT CAPTURES THE FIRST OF THREE EVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 10358895 ↗
• MalfunctionAug 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER, SPIROS® W/RED CAP, BAG HANGER THAT LEAKS AN UNSPECIFIED HAZARDOUS DRUG FROM THE TUBING OUT OF THE SPIROS AFTER THEY HAVE PRIMED THE LINE WITH FLUID. THIS RESULTS IN EXPOSURE TO HAZARDOUS MATERIAL AND WASTED PRODUCT TO REMAKE THE DOSE. THE SOLUTION INFUSED WAS MADE BY B. BRAUN MEDICAL. THE SOLUTION BAG WAS SPIKED WITH TUBING AT THE PORT, THEN THE TUBING WAS PRIMED WITH THE NORMAL SALINE SOLUTION PRIOR TO ADDITION OF THE DRUG. THE LEAK IS TYPICALLY NOT NOTICED UNTIL AFTER COMPOUNDING WITH THE UNSPECIFIED MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT CAPTURES THE SECOND OF THREE EVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 10358875 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173477. 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-1579-2021 · Mar 16, 2021 · Open, Classified
  REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a
• Z-1576-2021 · Mar 16, 2021 · Open, Classified
  REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1580-2021 · Mar 16, 2021 · Open, Classified
  REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administrat
• Z-1577-2021 · Mar 16, 2021 · Open, Classified
  REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1578-2021 · Mar 16, 2021 · Open, Classified
  REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration o
• Z-0704-2021 · Aug 31, 2020 · Open, Classified
  3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinn
• Z-0248-2021 · Jul 6, 2020 · Terminated
  6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149.