ICU Medical CL-80SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709069596), received between Oct 31, 2018 and Jun 24, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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-0347-2026 · 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A CHEMOLOCK¿ VIAL SPIKE, 20MM WOULD NOT ASPIRATE FLUIDS. THE CLINICIAN STATED THAT WHEN A 20 MM SPIKE WAS CONNECTED TO A VIAL OF STERILE WATER (10 ML) THEY WERE ABLE TO WITHDRAW LIQUID. HOWEVER, ONLY 8 ML WAS ABLE TO BE WITHDRAWN. FOR SOME REASON, FLUID ENTERED THE VIAL SPIKE¿S AIR VENT (BALLOON) SO THERE WAS A LOSS OF ABOUT 2 ML. A SAMPLE PHOTO WAS PROVIDED SHOWING THE DEFECTIVE PRODUCT. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591872 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ VIAL SPIKE, 20MM WHERE IT WAS REPORTED THE DEVICE WAS LEAKING DUE TO CONCAVE VIAL STOPPER. IT WAS ALSO REPORTED THAT THEY HAVE HAD ISSUES WITH LEAKING OCCURRING FROM BOTTLES OF CISPLATIN 100MG/100ML (TEVA) USING THE ICU MEDICAL CLOSED SYSTEM. THEY HAVE BEEN FOLLOWING THE DIRECTIONS PROVIDED TO TWIST THE CHEMOLOCK VIAL SPIKES BACK AND FORTH AFTER INSERTING INTO CONCAVE STOPPERS TO SEAT IT FULLY, BUT STILL AFTER FOLLOWING THESE INSTRUCTIONS, THEY ARE STILL LEAKING. THERE WAS UNKNOWN PATIENT INVOLVED AND UNKNOWN HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775369 ↗
• MalfunctionSep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CHEMOLOCK¿ VIAL SPIKE, 20MM WHERE A LEAK DUE TO CONCAVE VIAL STOPPER WAS REPORTED. IT WAS ALSO REPORTED THAT THE CUSTOMER HAS HAD ISSUES WITH LEAKING OCCURRING FROM A BOTTLE OF PACLITAXEL 300MG/50ML (ATHENEX) USING THE ICU MEDICAL CLOSED SYSTEM. THEY HAVE BEEN FOLLOWING THE DIRECTIONS PROVIDED TO TWIST THE CHEMOLOCK VIAL SPIKES BACK AND FORTH AFTER INSERTING INTO CONCAVE STOPPERS TO SEAT IT FULLY BUT STILL AFTER FOLLOWING THESE INSTRUCTIONS, THEY ARE STILL LEAKING. THERE WAS UNKNOWN PATIENT INVOLVED AND UNKNOWN HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764909 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Device Difficult to Setup or Prepare; Material Twisted/Bent

  WHEN USING CHEMOLOCK VIAL SPIKE 20MM BY ICU MEDICAL IT WAS DISCOVERED THAT THE END SPIKE THAT SHOULD GO INTO THE VIAL HAD A BENT TIP. THIS PREVENTED THE VIAL FROM BEING SPIKED. WHEN ANOTHER VIAL SPIKE WAS USED, THE SPIKE DID NOT FULLY PIERCE THROUGH THE RUBBER STOPPER OF THE PACLITAXEL, NDC (B)(4). THE CLAMPS OF THE VIAL SPIKE ON THE SIDES OF THE VIAL WERE FULLY SECURED AND THE SPIKE WAS ROTATED 90 DEGREES. WHEN THE VIAL WAS INVERTED THOUGH, THE CHEMO BEGAN THE LEAK THROUGH THE RUBBER STOPPER AND ONTO THE VIAL SPIKE AND THE HANDS OF THE TECHNICIAN MANIPULATING THE MEDICATION. BOTH THE VIAL OF CHEMO AND THE VIAL SPIKE WERE DISPOSED OF, BUT OTHER SPIKES OF THE SAME LOT NUMBER WERE KEPT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Chemical Exposure

  MAUDE report 14409614 ↗
• MalfunctionOct 31, 2018Particulates; Particulates

  THE EVENT INVOLVED A CHEMOLOCK VIAL SPIKE THAT DURING PREPARATION OF VIDAZA (AZACITIDINE), PARTICLES WERE NOTED INSIDE THE VIAL. THE CUSTOMER STATED THAT THIS "CORING" IS ONLY NOTED WITH THIS MEDICATION. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO MEDICAL AND SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 8024436 ↗

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-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• Z-0339-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• 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-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0361-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
• 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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• 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-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

…and 43 more.