ICU Medical CL-80S-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709077119), received between Sep 20, 2024 and Nov 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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-0348-2026 · 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING TO CHEMOLOCK CLOSED VIAL SPIKE W/SKIRT, 5 UNITS WHERE IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHERE THE MEDICINE COMES INTO THE VIAL. PATIENT INVOLVEMENT AND PATIENT HARM ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658948 ↗
• MalfunctionSep 20, 2024Particulates; Particulates

  A COMPLAINT WITH REGARDS TO CHEMOLOCK¿ CLOSED VIAL SPIKE W/SKIRT, 5 UNITS EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. IT WAS REPORTED THAT "BENDEKA WAS WITHDRAWN FROM TWO VIALS, EACH CONTAINING A CL-80S-5, FROM THE LOT MENTIONED. IT WAS WITHDRAWN INTO A 10ML SYRINGE WITH CL2000S. WHITE PARTICULATE WAS NOTICED BY THE PHARMACIST AND TECHNICIAN, WHO THOUGHT IT WAS CORING ALTHOUGH THE STOPPER WAS DARK GREY. A CL2100 WAS ATTACHED TO THE CL2000S ON THE SYRINGE AND A FILTER NEEDLE TO THE CL2100 AND INFUSED THE MEDICATION INTO THE BAG FILTERING OUT THE PARTICULATE MATTER. THE MATTER SHOULD BE SOMEWHERE IN THE NEEDLE, CL2100, CL2000S OR SYRINGES". THE SAMPLE DEVICE IS AVAILABLE FOR EVALUATION. THE PRODUCT WAS CONTAMINATED, CONTAINED BIOHAZARD, AND CHEMOTHERAPEUTIC AGENT. THE DATE OF INCIDENT WAS ON (B)(6) 2024 AT 9:00 A.M. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS DURING COMPOUNDING PRIOR TO INFUSING INTO BAG. THE MEDICATION INVOLVED WAS BENDEKA. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS NO HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272108 ↗

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-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0354-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• 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-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• 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-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-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-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

…and 43 more.