ICU Medical CLH-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709080416), received between May 23, 2025 and Nov 20, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

59 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT WAS REPORTED VIA USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4). THE EVENT OCCURRED 2 TIMES ON AN UNSPECIFIED DATE(S) IN OCTOBER - OCT 1ST, 2025, IS USED AS PLACEHOLDER. THE EVENT INVOLVED AN 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER AND THE CUSTOMER STATED THAT INOTUZUMAB WAS PICKED UP FROM PHARMACY WITH CHEMO SPIKE ADAPTER IN PLACE/SPIKED INTO CHEMO BAG. THE CHEMO SPIKE ADAPTER HAD A WHITE DRY SPIKE ADAPTER AND A BLUE CHEMO LOCK UPSIDE DOWN. THE HEALTHCARE PROFESSIONAL SPIKED THE WHITE SPIKE ADAPTER BUT THERE WAS SOME RESISTANCE WHEN SPIKING THE WHITE SPIKE ADAPTER. WHEN SHE WENT TO ADMINISTER THE INOTUZUMAB, THE NURSE DISCONNECTED THE SPIROS FROM THE BLUE MICROCLAVE/SIDE-PORT, AND THE MEDICATION STARTED TO QUICKLY LEAK OUT OF THE BLUE MICROCLAVE/SIDE PORT. THE SECOND DOSE WAS PRIMED WITH AN ADAPTER THAT HAD THE DOWNWARD FACING CHEMO LOCK, AND A WHITE SPIKE ADAPTER PIGTAIL. THE CHEMO LOCK WAS UTILIZED TO PRIME THE MEDICATION. WHEN SHE WENT TO ASSESS THE INFUSION UPON RETURNING, SHE NOTICED THAT THERE WAS A LARGE DROP OF MEDICATION COMING OUT OF THE BLUE MICROCLAVE/SIDE-PORT, HOWEVER, IT WAS NOT ACTIVELY DRIPPING, AS THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609516 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  AN EMAIL WAS RECEIVED WITH REGARDS TO AN 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER, ALLEGING AN UNSPECIFIED CHEMOTHERAPY SPILL DURING PATIENT USE. IT WAS REPORTED THAT THERE WAS A USER ERROR RESULTING IN A CHEMO SPILL. THE SPILL HAPPENED AS THE NURSE WENT TO CONNECT THE TUBING TO THE PATIENT. THE INTRAVENOUS (IV) SPIKE FELL OUT OF THE DRY SPIKE ADAPTER DUE TO THE PHARMACY TECH NOT FULLY TWISTING THE SPIKE INTO THE DRY SPIKE. NOTABLE BARRIER: MULTIPLE SHOULDER/WRIST REPETITIVE USE INJURIES OCCURRING IN THE PHARMACY DUE TO THE FORCE WITH WHICH ONE HAS TO USE TO INSERT THE SPIKE INTO THE DRY SPIKE ADAPTER. THE PATIENT AND ANOTHER REGISTERED NURSE (RN) IN THE ROOM WERE DIZZY AND SENT TO OCCUPATIONAL HEALTH, AND THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424136 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTED EVENT/COMPLAINT INVOLVED A 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER. THE BAG SPIKES WERE REPORTEDLY LEAKING DURING USE. THE EVENT OCCURRED BETWEEN (B)(6) 2025 AFTER BEING SPIKED WITH ADMINISTRATION TUBING, DURING INFUSION. THE MEDICATION INFUSING AT THE TIME OF EVENT WAS METHOTREXATE. THE CHEMO CAME IN CONTACT WITH THE PATIENT OR THE HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND SPILL KIT WAS USED. THERE WAS NO ADVERSE EVENT; HOWEVER THERE WAS AN UNSPECIFIED DELAY IN THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 22354922 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER. THE REPORT STATES THAT BAG SPIKES LEAKING WHEN IN USE. THE EVENT OCCURRED IN MULTIPLE DATES OVER (B)(6) JUST PRIOR TO INFUSION AFTER BEING SPIKED WITH ADMINISTRATION TUBING AND DURING INFUSION. THE MEDICATION INFUSING AT THE TIME OF EVENT WAS CYTARABINE. THE CHEMO DID COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND SPILL KIT WAS USED. PHOTO OF THE ACTUAL DEFECTIVE ITEM WAS PROVIDED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT BUT THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236239 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES BETWEEN 01-MAY TO 15-MAY AND INVOLVED 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTERS. THE CUSTOMER REPORTED THAT THE BAG SPIKES LEAK DURING PATIENT USE WHILE ADMINISTERING CYCLOPHOSPHAMIDE. THE CUSTOMER STATED THAT THE INCIDENTS OCCURRED JUST PRIOR TO INFUSION, AFTER BEING SPIKED WITH ADMINISTRATION TUBING AS WELL AS DURING INFUSION. THE CHEMO DID COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND SPILL KIT WAS USED. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY BUT THERE WAS NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216096 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITH REGARDS TO A 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER THAT THE BAG SPIKES WERE LEAKING WHEN IN USE JUST PRIOR TO INFUSION AFTER BEING SPIKED WITH ADMINISTRATION TUBING AND DURING INFUSION. THE CHEMO DID COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THERE WAS PATIENT INVOLVEMENT, NO HARM REPORTED BUT THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214863 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT EVENTS OCCURRED ON MULTIPLE DATES BETWEEN 01-MAY-2025 TO 15-MAY-2025 AND INVOLVED A 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER. THE CUSTOMER REPORTED THAT BAG SPIKES LEAK (ETOPOSIDE) PRIOR TO INFUSION/DURING INFUSION. THE CHEMO REPORTEDLY DID COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND SPILL KIT WAS USED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT BUT THERE WAS DELAY IN THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 22197465 ↗
• MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAPTER WHERE IT WAS REPORTED THE DEVICE LEAKED FROM THE BLUE END WHEN USED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078158 ↗

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-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-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• 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
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• 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-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• 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-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

…and 44 more.