ICU Medical CL-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709056985), received between Jun 28, 2019 and Mar 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Fluid/Blood Leak

  THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582455 ↗
• MalfunctionOct 30, 2025Particulates; Particulates

  THE ISSUE OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT. A LITTLE WHITE THING IN THE STRAW PART OF THE TUBING (THAT LOOKED LIKE GLUE) WAS REPORTED WHEN THE TECH OPENED THE PACKAGE. THE TECH DID NOT USE THE PRODUCT. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429995 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT THEY HAD A LEAK ON FRIDAY ORIGINATING FROM WHERE THE CHEMO LOCK PORT ATTACHES TO THE BAG ACCESS SPIKE ON THE CL-13. THE DRUG INVOLVED WAS CYCLOPHOSPHAMIDE. THE CUSTOMER STATED ALSO THAT THE ANGLE OF THE CHEMOLOCK DOESN¿T APPEAR TO BE FULLY PERPENDICULAR. SAMPLE PHOTO WAS PROVIDED SHOWING THE SAMPLE.

  Patient problems: Insufficient Information

  MAUDE report 21639110 ↗
• MalfunctionAug 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY EVENT REPORT (MW5087812) WAS RECEIVED, WHICH STATED THE FOLLOWING " CHEMOLOCK CL-13 BAG SPIKE SLID COMPLETELY OUT OF 250 ML NORMAL SALINE BAG CONTAINING CHEMOTHERAPY. THIS RESULTED IN EXPOSURE AND A CHEMOTHERAPY SPILL RESPONSE. THE BAG SPIKE WAS CONFIRMED TO BE COMPLETED SEATED BY THE PHARMACIST COMPLETING ADMIXTURE. NURSE THAT STARTED ADMINISTRATION PROCESS DID NOT PULL ON THE CONNECTION; HOWEVER, WHEN HANGING THE BAG, THE SPIKE SLID OUT RESULTING IN A HD SPILL.¿

  Patient problems: Chemical Exposure

  MAUDE report 8902587 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT THAT THE CUSTOMER REPORTED THE SPIKE SLID OUT OF THE BAG AT THE BEGINNING OF THE INFUSION. THE CUSTOMER REPORTED THEY HAVE NOT EVEN STARTED IT AND WHEN THEY WERE HOOKING THE BAG FOR INFUSION, IT POPPED OUT. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE EVENT AND A DELAY IN THERAPY SINCE THEY HAD TO RECOMPOUND THE DRUG. THERE WAS CLINICAL STAFF EXPOSURE HOWEVER IT IS REPORTED THE STAFF WAS JUST FINE, NO MEDICAL INTERVENTION WAS PROVIDED, AND A DECONTAMINATION PROCESS WAS FOLLOWED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8785789 ↗
• MalfunctionJun 28, 2019Fluid/Blood Leak; Loose or Intermittent Connection; Detachment of Device or Device Component; Device Fell

  COMPOUNDED STERILE PRODUCT WAS PREPARED IN NS 100 ML PARTIAL FILL IN 150 ML PAB CONTAINER MANUFACTURED BY B. BRAUN MEDICAL INC. THIS WAS INTENDED TO BE ADMINISTERED TO PT THROUGH APPX 1.5 ML, CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT MANUFACTURED BY ICU MEDICAL INC. EVENT OCCURRED WHILE FINAL PRODUCT WAS BEING ADMINISTERED TO PT AND THE BAG SPIKE FELL OUT OF THE BAG RESULTING IN MEDICATION SPILL. BAG SPIKE WAS FOUND TO BE LOOSELY ATTACHED TO B. BRAUN BAG. ADD'L SPILLS HAVE OCCURRED USING B. BRAUN BAGS AND ICU MEDICAL CHEMOLOCK BAG SPIKES IN THE PAST. THE SPIKE FITS TIGHTLY INTO OTHER BAG PORTS AND THE PROBLEM IS ISOLATED TO THE 150 ML PAB CONTAINER. FDA SAFETY REPORT ID(S)# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748719 ↗

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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• 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-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• 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-0363-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• 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-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-0352-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

…and 44 more.