ICU Medical CL-82Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709085695), received between Oct 24, 2023 and Oct 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

58 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.

Recalls naming this device

1. Sep 8, 2025Class IIOpen, Classified

   Port weld of drug transfer device may separate or break during use and potentially result in a leak.

   Z-0349-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 27, 2022Class IIOpen, Classified

   Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

   Z-1681-2022 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Crack; Crack

  EVENT OCCURRED REGARDING A CHEMOLOCK 13MM CLOSED VIAL SPIKE WHERE IT WAS REPORTED THAT THE TECH WENT TO SPIKE THE ADAPTER ONTO THE VIAL AND THE SPIKE BROKE OFF. THERE WAS PATIENT INVOLVEMENT, AND STAFF EXPOSURE. THERE WAS ALSO DELAY IN THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 23432747 ↗
• MalfunctionJun 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT A CHEMOLOCK¿ 13MM CLOSED VIAL SPIKE GENERATED A NO-FLOW SCENARIO DURING PATIENT USE. THE REPORT STATED THAT THE VIAL CL-82 WAS USED TO RECONSTITUTE THE VIAL OF DACTINOMYCIN 0.5 MG. THE ISSUE ENCOUNTERED WAS THAT THE DILUENT PASSED THROUGH THE CHEMOLOCK BUT WENT DIRECTLY INTO THE BALLOON OF THE VIAL. THE EVENT OCCURRED ON 25-APR-2024. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473995 ↗
• MalfunctionOct 24, 2023Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A CHEMOLOCK¿ 13MM CLOSED VIAL SPIKE IN WHICH THE CUSTOMER REPORTED THAT AS THE NURSE WAS MIXING A BACILLE CALMETTE-GUERIN (BCG) DOSE WITH VERITY BRAND WHICH REQUIRES RECONSTITUTION OF 2 VIALS INTO ONE SYRINGE. DILUENT WAS ADDED TO BOTH VIALS TO BEGIN WITH SO IT COULD DISSOLVE THE POWDERED DRUG. THEN THE NURSE REMOVED THE DRUG FROM ONE VIAL, THEN THE OTHER. WHEN ATTEMPTING TO INJECT THE AIR FROM THE SYRINGE BACK INTO THE 2ND VIAL, THE AIR KEPT PUSHING BACK INTO THE SYRINGE. SO THE NURSE WAS UNABLE TO REMOVE THE AIR FROM THE SYRINGE. THERE WERE NO DEFECTS NOTED ON THE TUBING SET BEFORE IT WAS USED. THE DRUG WAS DELIVERED TO THE PATIENT. IT WAS INTENDED FOR BLADDER INSTILLATION. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999266 ↗

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-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-0333-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
• 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-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0362-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
• 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-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
• Z-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• 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-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0365-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

…and 43 more.