ICU Medical CL-10TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709120037), received between Feb 18, 2025 and Feb 18, 2025 — 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.

• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE A LEAK WAS REPORTED. THE LEAKAGE WAS FOUND AFTER 35MINUTES PASSED FROM WHEN THE ADMINISTRATION STARTED. ONE ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A CHEMOSAFELOCK INFUSION SET. IN ADDITION, THE INDIVIDUAL PACKAGE, AND A SALINE BAG (500ML/FUSO) WERE ALSO RECEIVED. -WITH ¿AS-RECEIVED¿ CONDITION, WE CONNECTED THE ACTUAL SAMPLE TO OUR IN-HOUSE SALINE BAG AND CHECKED LIQUID FLOW UNDER GRAVITY. AS A RESULT, THE LEAKAGE WAS CONFIRMED AT THE BACK OF CLIPS. -ON THE OTHER HAND, WHEN WE PERFORMED LIQUID FLOW CHECK UNDER GRAVITY AFTER REPLACED THE KLBS001U3 TO OUR FACTORY SAMPLE, NO LEAKAGE WAS OBSERVED. -CT INSPECTION WAS PERFORMED ON THE CONNECTION BETWEEN THE ACTUAL SAMPLE AND THE KL-MSU3 OF INFUSION SET, WHEREIN THE DEFORMED CONDUIT AND A GAP BETWEEN THE CONDUIT AND SEAL PART WERE CONFIRMED. THE EVENT WAS NOTED DURING INFUSION OF ANTICANCER DRUG AND WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO ADVERSE OPERATOR CONSEQUENCES, NO UNPROTECTED CHEMO EXPOSURE AND NO MEDICAL/SURGICAL INTERVENTION WERE REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406762 ↗

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-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• Z-0344-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• Z-0331-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• Z-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0354-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• Z-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• 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-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

…and 45 more.