ICU Medical CL2000S-RCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709091887), received between May 7, 2021 and Sep 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694632 ↗
• MalfunctionAug 12, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ W/RED CAP THAT EXPERIENCED NO FLOW DURING USE. THE REPORTER STATED THAT CHEMO TUBING SET UP WITH CONNECTORS. THE CHEMO WOULD NOT TRANSFUSE OR WOULD NOT FLOW WHEN CHEMO-LOCK ATTACHED TO IV TUBING, AND PUMP KEPT SHOWING PROXIMAL OCCLUSION. CHEMO CONNECTORS DISCONNECTED AND RECONNECTED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790189 ↗
• MalfunctionJan 25, 2024Fluid/Blood Leak; Premature Separation; Fluid/Blood Leak; Premature Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ W/RED CAP WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS ATTACHED TO A PATIENT WHEN IT WAS NOTICED THAT THE MALE AND FEMALE CHEMOLOCK ADAPTERS CAME UNDONE AND FEW DROPS OF CHEMO LEAKED. THE CUSTOMER REPORTED THAT WHEN THE NURSE DID AN ASSESSMENT AND REATTACHED THEM, THEY COULD EASILY BE PULLED BACK APART, SO THEY WERE REPLACED WITH A NEW SET. THERE WAS PATIENT INVOLVEMENT; NO HARM THAT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581513 ↗
• MalfunctionJan 25, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ W/RED CAP WHERE IT WAS REPORTED THAT THE PRODUCT LEAKED WHILE ATTACHED TO A PATIENT. THE MALE AND FEMALE CHEMOLOCK ADAPTERS CAME UNDONE AND FEW DROPS OF CHEMO LEAKED. WHEN THE NURSE DID AN ASSESSMENT AND REATTACHED THEM, THEY COULD EASILY BE PULLED BACK APART, SO THEY WERE REPLACED WITH A NEW SET. THERE WAS PATIENT INVOLVEMENT, AND NO HARM THAT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580072 ↗
• MalfunctionNov 2, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK® W/RED CAP WHERE IT WAS REPORTED THAT THE CUSTOMER WAS HAVING REGULAR DISCONNECTIONS BETWEEN CL2000S AND THEIR BD ALARIS TUBING DURING PATIENT USE. THEY DISCARDED THE PRODUCT IN QUESTION, BUT THEY WERE ABLE TO RECREATE THE CONCERNS THEY WERE HAVING WITH THEIR TUBING AND CL2000S, WHICH CAN BE SENT IN FOR REVIEW. OTHER PRODUCTS INVOLVED AT TIME OF EVENT: BD TUBING WITH LIST NUMBER 2432-0007 AND EXT TUBING WITH LIST B9061 AND LOT 13671625. THE PRODUCT WAS IN USE FOR 18 HOURS. ADDITIONALLY, THE CUSTOMER STATED THAT THEY FOUND A PATIENT DISCONNECTED FROM THEIR LINE WITH DRUG AND BLOOD LEAKING OUT. MEDICATION INVOLVED WAS BLINATUMOMAB. THE EVENT OCCURRED AT 4PM. THERE WAS PATIENT INVOLVEMENT, NO HARM/ADVERSE EVENT, AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053693 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK® W/RED CAP THAT THE CUSTOMER REPORTED THE NURSE HAD JUST FINISHED HER INTRAVENOUS (IV) PUSH OF ADRIAMYCIN AND UPON DISCONNECTING SHE OBSERVED A DROP OF RED ON CL2100. THE NURSE USED THE ALCOHOL SWAB TO WIPE THE DROP OFF AND DISCARDED THE DEVICE. THE DEVICE REPLACED WITH ANOTHER WITHOUT AN ISSUE. THERE WAS NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793863 ↗

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-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology 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-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0334-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• 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-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0354-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
• 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-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100

…and 45 more.