ICU Medical CL3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887709072923), received between Aug 2, 2022 and Nov 11, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Particulates; Particulates

  A COMPLAINT WAS RECEIVED REGARDING 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP THAT EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE IS UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528673 ↗
• MalfunctionNov 11, 2025Particulates; Particulates

  A COMPLAINT WAS RECEIVED REGARDING 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP THAT EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE IS UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528602 ↗
• MalfunctionNov 11, 2025Particulates; Particulates

  A COMPLAINT WAS RECEIVED REGARDING 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP THAT EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE IS UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528489 ↗
• MalfunctionNov 11, 2025Particulates; Particulates

  A COMPLAINT WAS RECEIVED REGARDING 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP THAT EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE IS UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528431 ↗
• MalfunctionNov 11, 2025Particulates; Particulates

  A COMPLAINT WAS RECEIVED REGARDING 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP THAT EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE IS UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528025 ↗
• MalfunctionOct 28, 2025Particulates; Particulates

  THE COMPLAINT INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP. AN UNIDENTIFIED WHITE SUBSTANCE WAS REPORTED IN THE TUBE OR THERE WAS VISIBLE WHITE SUBSTANCE IN FLUID PATH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409165 ↗
• MalfunctionSep 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED BETWEEN (B)(6) 2025 AND INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE IT WAS REPORTED THAT THE PRODUCT HAS AN UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THE ISSUE WAS IDENTIFIED WHEN THE REGISTERED NURSE (RN) WAS PRIMING THE TUBING WITH CHEMOTHERAPY FOR A SPECIFIC PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021950 ↗
• MalfunctionSep 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED DURING VARIOUS DATES BETWEEN 15-AUG-2025 TO 18-AUG-2025 AND INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE IT WAS REPORTED THERE WAS AN UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THE ISSUE WAS IDENTIFIED WHEN THE REGISTERED NURSE (RN) WAS PRIMING THE TUBING WITH CHEMOTHERAPY FOR A SPECIFIC PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019969 ↗
• MalfunctionSep 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED DURING VARIOUS DATES BETWEEN 15-AUG-2025 TO 18-AUG-2025 AND INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE IT WAS REPORTED THERE WAS AN UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THE ISSUE WAS IDENTIFIED WHEN THE REGISTERED NURSE (RN) WAS PRIMING THE TUBING WITH CHEMOTHERAPY FOR A SPECIFIC PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019659 ↗
• MalfunctionSep 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED DURING VARIOUS DATES BETWEEN 15-AUG-2025 TO 18-AUG-2025 AND INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE IT WAS REPORTED THERE WAS AN UNIDENTIFIED WHITE SUBSTANCE IN TUBE. THE ISSUE WAS IDENTIFIED WHEN THE REGISTERED NURSE (RN) WAS PRIMING THE TUBING WITH CHEMOTHERAPY FOR A SPECIFIC PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019449 ↗
• MalfunctionMay 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER. A SPLIT IN THE LINE THAT WAS EASILY VISIBLE WAS REPORTED WHILE A PATIENT WAS GETTING AN INFUSION OF AN UNSPECIFIED MONOCLONAL ANTIBODY. AS A RESULT, A LIGHT MIST SPRAYED ONTO THE PATIENT'S FACE. THE PATIENT DID NOT COMPLAIN. A SMALL MIST WENT ONTO THE NURSE'S CLOTHING. ALTHOUGH THERE WAS A DELAY IN THE PATIENT'S THERAPY, THERE WAS NO HARM TO EITHER THE PATIENT OR THE NURSE AS A RESULT OF THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414873 ↗
• MalfunctionAug 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP. IT WAS REPORTED THAT WHITE SEDIMENT WAS OBSERVED IN THE TUBING. IT WAS ALSO STATED THAT WHEN THE TUBING WAS CUT OPEN, THE WHITE MATTER CAN BE REMOVED. THE PRODUCT PACKAGE WAS SEALED AND NOT EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164293 ↗
• MalfunctionAug 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND PRODUCT INVOLVED AN 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP. IT WAS REPORTED THAT WHITE SEDIMENT WAS OBSERVED IN THE TUBING. IT WAS ALSO STATED THAT WHEN THE TUBING WAS CUT OPEN, THE WHITE MATTER CAN BE REMOVED. THE PRODUCT PACKAGE WAS SEALED AND NOT EXPIRED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164236 ↗
• MalfunctionAug 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP IT WAS REPORTED THAT WHITE SEDIMENT WAS OBSERVED IN THE TUBING DURING PRIMING OF THE IV TUBING WITH SALINE (PRIOR TO ATTACHING TO THE PATIENT). IT WAS ALSO STATED THAT WHEN THE TUBING WAS CUT OPEN, THE WHITE MATTER CAN BE REMOVED. THE PRODUCT PACKAGE WAS SEALED AND NOT EXPIRED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164179 ↗
• MalfunctionAug 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE THE CUSTOMER NOTICED A WHITE SEDIMENT IN THE TUBING. SHE ADDED THAT WHEN THE TUBING WAS CUT OPEN, THE WHITE MATTER CAN BE REMOVED WHICH IS A RISK FOR PATIENTS. IT WAS ALSO REPORTED THAT ANOTHER PRODUCT WAS OPENED (DIFFERENT LOT NUMBER) AND THE TUBING HAS THE SAME ISSUE. THEY STARTED INSPECTING PACKAGES OF CL3020 AND MULTIPLE PIECES (FROM A DIFFERENT LOT NUMBER) HAD WHITE SEDIMENT PRESENT. SHE ALSO STATED THAT THE PRODUCT PACKAGE WAS SEALED AND NOT EXPIRED. A SYSTEMIC TREATMENT HAS A VERY HIGH TURNOVER OF PRODUCT AS THEY HAVE HIGH USAGE. SHE WOULD NOT THINK THIS PACKAGE HAS SAT FOR LONG BUT UNABLE TO GIVE AN EXACT TIME FRAME THESE ITEMS ARE STOCKED DAILY FROM THEIR STORES. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147182 ↗
• MalfunctionAug 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, SPIROS®, BAG HANGER, DROP-IN RED CAP WHERE IT WAS NOTICED A WHITE SEDIMENT IN THE TUBING. THE CUSTOMER ADDED THAT WHEN THE TUBING WAS CUT OPEN, THE WHITE MATTER CAN BE REMOVED WHICH IS A RISK FOR PATIENTS. IT WAS ALSO STATED THAT THE PRODUCT PACKAGE WAS SEALED AND NOT EXPIRED. A SYSTEMIC TREATMENT HAS A VERY HIGH TURNOVER OF PRODUCT AS THEY HAVE HIGH USAGE. THE CUSTOMER DOES NOT THINK THIS PACKAGE HAS SAT FOR LONG BUT UNABLE TO GIVE AN EXACT TIME FRAME THE ITEM ARE STOCKED DAILY FROM THEIR STORES. THEY STARTED INSPECTING PACKAGES OF CL3020 AND MULTIPLE PIECES HAD WHITE SEDIMENT PRESENT (DIFFERENT LOT NUMBER). THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147173 ↗

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-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• 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-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-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-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0360-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• 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

…and 45 more.