ICU Medical AHCL-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709069244), received between Jul 23, 2024 and Jul 23, 2024 — classified as 1 malfunction.

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

• MalfunctionJul 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINT/EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE. WHITE FOREIGN MATERIAL WAS REPORTEDLY SUSPENDED IN A MATING SYRINGE. THIS ISSUE WAS IDENTIFIED DURING DRUG PREPARATION, AND BEFORE ANY USE BY ANY PATIENT. THE SAMPLE INVOLVED WAS CONNECTED TO A SALINE BOTTLE (50ML). IN ADDITION, THERE WAS AN ITEM NUMBER KL-MSU3 DEVICE AND A SYRINGE (WITH SOLUTION) INVOLVED DURING THE COMPLAINT/EVENT.. UPON CHECKING THE SOLUTION IN THE SYRINGE, THE CUSTOMER CONFIRMED A WHITE FOREIGN MATTER, WHICH MEASURED 1MMX0.3MM. AFTER REMOVING THE ACTUAL AAMPLE FROM THE SALINE BOTTLE, THE SPIKE TIP WAS CONFIRMED TO BE SLIGHTLY CHIPPED OFF. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED BY THE CUSTOMER ON THE FOREIGN MATTER. THE RESULT SHOWS A SPECTRUM SIMILAR TO ABS RESIN. THE CUSTOMER INDICATED THAT IT MAY HAVE BEEN DUE TO A FLASH POSSIBLY PRESENT ON THE TIP, AND IT CHIPPED OFF WHEN PUNCTURED INTO THE SALINE BOTTLE; FINALLY IT INTRUDING INTO THE SOLUTION. THE REPORTED ISSUE WAS CONSIDERED A PRODUCTION-ORIGIN ISSUE. THE DEVICE WAS CHANGED OUT OR REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO IMPACT ON ANY PATIENT, NOR ANY MEDICAL INSTITUTION WORKER AS A RESULT OF THIS COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812992 ↗

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-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• Z-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• 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-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• 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-0331-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• Z-0344-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• Z-0354-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

…and 45 more.