ICU Medical CL2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00887709057005), received between May 28, 2020 and Sep 16, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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. Sep 8, 2025Class IIOpen, Classified

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

   Z-0350-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792809 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED AN ISSUE WITH A CHEMOLOCK¿ PORT DEVICE. WHEN THE NURSE CHECKED THE PATIENT'S LINE, SHE REPORTED (UNSPECIFIED) CHEMOTHERAPY LEAKAGE FROM THE CHEMOLOCK COMPONENTS INTO AN AQUA GUARD. THE RN HAD PREVIOUSLY PREPARED PACLITAXEL USING CHEMOLOCK COMPONENTS CL2000S AND CL2100. AFTER THE LEAKAGE WAS IDENTIFIED, THE CHEMO WAS STOPPED, AND A NEW TUBING WAS SET UP AND PRIMED. THE PATIENT'S CHEMO TREATMENTS WERE DELAYED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283186 ↗
• MalfunctionOct 29, 2025Break; Break

  EVENT OCCURRED REGARDING A CHEMOLOCK¿ PORT WHERE IT WAS REPORTED THAT THE CHEMOCLAVE PORT IS FALLING APART. THEY REPORTED THAT IT OCCURRED WITH SEVERAL PATIENTS OVER THE WEEKEND. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING INFUSION. MEDICATION USED WAS CHEMO (BIOHAZARD). THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414517 ↗
• MalfunctionSep 8, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK PORT. IT WAS REPORTED THE CL2100 IS COMING DISCONNECTED FROM THE NEEDLELESS CONNECTORS ON THE Y-SITE OF THEIR B BRAUN PUMP TUBING (CARESITE NEEDLE-FREE CONNECTOR) AND NEXUS CONNECTOR THAT IS ON THE PATIENT'S CENTRAL LINE. WHEN THE CL2100 POPS OFF THE NEEDLELESS CONNECTOR WHILE CONNECTED TO THE CL2000S, THIS RESULTS IN A CHEMO SPILL/EXPOSURE. THE LEAK WAS COMING FROM THE Y CONNECTOR AND THE HUB AT THE PATIENT WITH THE NEXUS TKO. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994461 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A CHEMOLOCK PORT WHERE THEY REPORTED THAT DOXORUBICIN WAS ADMINISTERED THROUGH PVAD WITH CHEMOLOCK CONNECTOR AND COMPATIBLE SYRINGE CONNECTOR, AND WHEN DISCONNECTED TO BEGIN NEXT SYRINGE, THE CHEMOLOCK LEAKED ABOUT A QUARTER SIZED AMOUNT OF DRUG ONTO ABSORBENT PAD. THEY FURTHER MENTIONED THAT THE NURSE WAS SURE THE PORT WAS CONNECTED PROPERLY TO THE IV TUBING CONNECTOR WHEN THEY INJECTED THE DOXORUBICIN HD WITH INJECTOR CL2000S ON SYRINGE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842286 ↗
• MalfunctionMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ PORT WITH ITEM NUMBER CL2100 THAT WAS ASSOCIATED WITH BACKFLOW RESULTING IN LEAKAGE THROUGH SYRINGE. IT WAS REPORTED THAT WHEN THE STAFF WAS ABOUT TO ADMINISTER METHOTREXATE, THE CHEMOLOCK MALFUNCTIONED. ADDITIONALLY, UPON LOCKING THE CHEMO SYRINGE ONTO THE PORT THAT WAS ON THE PRIMARY LINE SUDDENLY NOTICED RAPID BACK FLOW OF NORMAL SALINE INTO THE CHEMO SYRINGE, BECAUSE THIS HAPPENED RAPIDLY AND BECAUSE THE VOLUME OF METHOTREXATE WAS SO SMALL (0.3ML) THE PLUNGER WAS PUSHED OUT OF THE SYRINGE AND A SMALL AMOUNT OF METHOTREXATE SPILLED ONTO A BLUE PAD THAT WAS UNDER THE CHEMO SYRINGE. THE EVENT OCCURRED ON 22-APR-2025 DURING ADMINISTRATION. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. IT WAS NOTED THAT THE SYRINGE AND CHEMOLOCK USED. 0.3ML WAS THE INITIAL VOLUME, WHEN ATTACHED TO PORT AND SALINE LINE, SALINE PUSH BACK INTO SYRINGE. A SAMPLE PICTURE WAS PROVIDED SHOWING THE PRODUCT. IT WAS NOTED THAT THE MANUFACTURER OF NORMAL SALINE IS BAXTER AND THE NDC NUMBER IS B1322 WITH DIN 00060208, THERE ARE NO ISSUES RELATED TO THE NS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093189 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ PORT WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) NOTICED A LEAK AT THE CONNECTION BETWEEN THE SECONDARY TUBING AND THE CLOSED-SYSTEM TRANSFER DEVICE (THE CLEAR PLASTIC PIECE THAT CONNECTS THE FLEXIBLE TUBING AND THE BLUE CHEMOLOCK PIECE OF THE SECONDARY TUBING). THE DRUG INVOLVED IS FLUDARABINE 78.75MG IN NS 107ML. 15-20CCS WERE ESTIMATED SPILLED. A SPILL KIT WAS USED. PATIENTS OR STAFF DID NOT NEED MEDICAL ATTENTION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061280 ↗
• MalfunctionFeb 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CHEMOLOCK¿ PORT WHERE IT WAS REPORTED THAT THE RN PLACED A PAUSE ON THE INFUSION AND TURNED ON LIGHTING. RN FELT THE LINE AND SAW A DROP OF FLUID, HOWEVER NO COLLECTION OF FLUID ON BEDDING, UNDER OR AROUND PATIENT AS WELL AS PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) INSERTION AND DRESSING WAS DRYING. RESTARTED INFUSION AND MONITORED ALL CONNECTIONS IN WHICH A DROP OF FLUID STARTED TO COME FROM THE SIDE OF THE MICROCLAVE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427382 ↗
• MalfunctionNov 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ PORT THAT EXPERIENCED LEAKAGE. THE REPORT STATED THAT THE CHEMOLOCK PORT LUER LOCK END BECAME SEPARATED FROM PRIMARY LINE SPILLING MODERATE AMOUNT OF CYTOTOXIC, HD1 MATERIAL ONTO A STAFF MEMBER AND FLOOR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THE TUBING THAT WAS COLLECTED IS ONLY THE CHEMOLOCK COMPONENTS. A HAZARDOUS CHEMOTHERAPY AGENT WAS INFUSED THROUGH THE TUBING. THE DRUG WAS CALLED CYCLOPHOSPHAMIDE AND IS A GROUP 1 HAZARDOUS DRUG. A SAMPLE PHOTO WAS PROVIDED SHOWING THE DEFECTIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767017 ↗
• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ PORT WHERE THE CUSTOMER REPORTED A LEAK. WHEN THE ETOPOSIDE WAS COMPLETED, AND THE LINE FLUSHED, MESNA PIGGYBACK WAS RUNNING. THE PATIENT WAS LAYING ON HIS SIDE AND NOTED A WET AREA ON HIS SHEET (MAYBE 10ML WORTH OF FLUID) AND A SMALL WET AREA ON HIS SHIRT. THE CHEMO LOCK PORT CLOSEST TO THE PATIENT WAS LEAKING. WHEN I TWISTED THE LOCK, IT WAS A LITTLE LOOSE. CHECKED THE PATIENT¿S SKIN AND IT WASN'T WET, NO RASH, REDNESS OF IRRITATION. THEY PAGED THE MEDICAL DOCTOR CALLED CHEMO PHARMACIST SINCE ETOPOSIDE HAS RECENTLY BEEN IN LINE. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694506 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CHEMOLOCK¿ PORT GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT WHEN THEY WERE CHECKING FOR BLOOD RETURN ON THEIR PATIENT'S CENTRAL LINE BEFORE STARTING CHEMO, THEY FELT A SPLASH OF LIQUID COME FROM THE TUBING. THE TUBING WAS REPLACED BEFORE STARTING THE DAY'S CHEMO. IT WAS DISCOVERED THAT THE FLUID THAT WAS FLASHED ONTO THE FACE WAS A BLUE CHEMO ADAPTOR THAT HAD CHEMO RUNNING THROUGH IT FOR THE PAST FOUR DAYS. THE CLINICIAN DOES STILL HAVE THE AFFECTED ITEM ON HAND AND IS AVAILABLE TO BE RETURNED IF NEEDED. THERE WAS NO CHEMO SPILL AND THE REGISTERED NURSE (RN) WASHED UP FACE PER PROTOCOL. NO SPILL KIT WAS USED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569231 ↗
• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CHEMOLOCK PORT GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE LEAKING OF CHEMOTHERAPY WAS NOTICED BETWEEN THE CHEMOLOCK PORT CL2100 AND CHEMOLOCK INJECTOR CL2000S. THERE WAS NO SAMPLE RETURN AVAILABLE TO BE TESTED, THE SAMPLE WAS DISCARDED. THERE WAS NO SAME LOT DEVICE SAMPLE AVAILABLE AND NO MATING DEVICE AVAILABLE TO BE TESTED. SAMPLE PHOTOS WERE PROVIDED; THE FIRST TWO PHOTOS SHOWED A LEAK THAT CAUSED A CHEMOTHERAPY SPILL, AND THE THIRD PHOTO SHOWED THE BLUE CLAVE OF THE PRIMARY SET. THERE WAS NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY, NO MED/SURG INTERVENTION REQUIRED AND THE DEVICE CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474225 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT THAT, ON AN UNKNOWN DATE IN (B)(6): ¿THE CONNECTION BETWEEN THE SECONDARY CLAVE AND THE CHEMO LOCK CL2100 CAUSED LEAKING WHEN CHEMO WAS INFUSING. THE SPILLS WERE SMALL AND CLEANED. THE AREA WAS SANITIZED. SPILL WAS NOTED TOWARDS THE END OF PATIENT'S TREATMENT.¿ THE EVENT OCCURRED AT THE HOSPITAL USER FACILITY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461757 ↗
• MalfunctionSep 20, 2024Particulates; Particulates

  A COMPLAINT INVOLVING A CHEMOLOCK¿ PORT 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. 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 20268755 ↗
• MalfunctionSep 10, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT A PORT CHEMOLOCK CA/50 DISCONNECTED DURING PATIENT USE. THE REPORT STATED, "CHEMO LOCK FAULTY, DISCONNECTED FROM LINE AND SPONTANEOUSLY DETACHED." ONE SAMPLE IS RETAINED AND IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185719 ↗
• MalfunctionAug 22, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A CHEMOLOCK¿ PORT WHERE THE CUSTOMER REPORTED THAT IT WAS DISCONNECTING FROM THE CHEMO LINE. THE CHEMO APPEARS TO HAVE SPILLED AND THE LINE WAS CLAMPED AND PUMPED WAS PAUSED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031105 ↗
• MalfunctionMay 24, 2024No Flow; No Flow

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT. THE REPORT STATED THAT THERE WAS DIFFICULTY WITH PRIMING OF LINE USING ALARIS TUBING. THERE WAS NO REPORT OF HUMAN HARM AS A RESULT OF THIS COMPLAINT/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393483 ↗
• MalfunctionMay 24, 2024Disconnection; Disconnection

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT. THERE WERE THREE INSTANCES WHEN IT HAPPENED: (1) CSTD GOT EASILY DISCONNECTED WITH MINIMAL FORCE WITH DIFFERENT BD SETS. THE SET LOCKS AND SPINS BUT DISCONNECTS WITH MINIMAL TOUCHING OF WINGS. THERE WAS NO REPORT OF HUMAN HARM AS A RESULT OF THIS COMPLAINT/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393447 ↗
• MalfunctionMay 24, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT. THE REPORT STATED THAT DEVICE WAS ATTACHED TO SPIROS AND WITH IM & SUBCUTANEUS INJECTIONS, SPIROS ALLOWED NEEDLE TO CONTINUE TO SPIN BUT DISCONNECTED WHICH CAUSED LEAKS. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393394 ↗
• MalfunctionMay 23, 2024No Flow; No Flow

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT. THE COMPLAINANT REPORTED THAT THEY GET SYMPATHETIC FLOW WHEN USING A SECONDARY SET. THE FOLLOWING WAS ENCOUNTERED: -NOT PULLING, DEMONSTRATING SOME LEVELS OF OCCLUSION, WHEN USING SECONDARY SET THAT WERE: -SPINNING, -NON-SPINNING, -WITH BONDED SET CL3511 AND-WHEN A CL211 WAS ATTACHED TO THE SMARTSITE ABOVE THE PUMP. THERE WAS NO REPORT OF HUMAN HARM AS A RESULT OF THIS COMPLAINT/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387147 ↗
• MalfunctionJan 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT. IT WAS REPORTED THAT THE PRODUCT WAS ATTACHED TO A PATIENT WHEN A LEAK WAS TRYING TO OCCUR. THE MALE AND FEMALE CHEMOLOCK ADAPTERS CAME UNDONE AND FEW DROPS OF UNSPECIFIED CHEMOTHERAPY DID LEAK. WHEN THE NURSE DID AN ASSESSMENT AND REATTACHED THEM, THE ADAPTERS COULD EASILY BE PULLED BACK APART, SO THEY WERE REPLACED WITH A NEW SET. THERE WAS PATIENT INVOLVEMENT, AND NO HARM THAT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18549207 ↗
• MalfunctionJan 13, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT THAT REPORTEDLY LEAKED A FEW DROPS OF CHEMOTHERAPY. DURING AN INFUSION, THE PATIENT ALERTED THE NURSE THAT THE LINES HAD COME UNDONE. WHEN THE NURSE WENT TO LOOK INTO THE ISSUE, IT WAS IDENTIFIED THAT THE FEMALE AND MALE CONNECTORS ON THE CHEMOLOCKS CAME APART. LUCKILY, THE PATIENT WAS ABLE TO SPOT THE ISSUE AND REPORT IT QUICKLY (WHICH AVERTED A FULL CHEMO SPILL). THE NURSE KNEW THAT THE PIECES WERE CONNECTED BEFORE THEY LEFT THE ROOM. THE NURSING STAFF RECONNECTED THE PIECES TO INVESTIGATE, AND THEY WERE ABLE TO BE PULLED APART VERY EASILY. THE STAFF CHANGED OUT THAT PART OF THE LINE. THE NEXT (REPLACEMENT) FEMALE AND MALE CONNECTORS FIT MORE SECURELY AND WERE NOT ABLE TO BE PULLED APART. THERE WAS NO HUMAN HARM WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509567 ↗
• MalfunctionOct 31, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THE COMPLAINT INVOLVED A CHEMOLOCK¿ PORT THAT WAS REPORTED TO BE PULLING FROM BOTH THE PRIMARY BAG AND THE SECONDARY BAG AT THE SAME TIME DURING INFUSION. THE PRODUCT HAD BEEN USED BEFORE THE ISSUE WAS NOTICED. THERE WAS NO LEAKING FROM THE DEVICE. THE ISSUE RESULTED IN PROLONGED INFUSION TIME AND A DELAY IN THERAPY. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038311 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MM 10/5/23 THE EVENT INVOLVED A CHEMOLOCK¿ PORT AND OCCURRED ON AN UNSPECIFIED DATE. IT WAS REPORTED THE END USER NOTED AT LEAST 3-4 ISSUES WITH THE CHEMOLOCKS AND HAVE HAD A COUPLE OF SPILLS ACROSS INFUSION SITES. IT WAS ALSO REPORTED THAT THE FIRST COUPLE OF TIMES, IT WAS NOT KNOWN IF IT WAS THE INJECTOR OR THE PORT. IT WAS ALSO STATED THAT ONE BIG CHEMO SPILL THAT HAPPENED WHILE THE CHEMOTHERAPY WAS INFUSING. THE SET UP OF THE PRODUCT WAS BOTH PRODUCTS WERE PLACED ON TUBINGS PRIOR TO CONNECTING TO PATIENTS. THE ISSUE WAS DURING PATIENT USE. THE MEDICATION INVOLVED WAS PACLITAXEL/ TAXOL. IT WAS ALSO REPORTED THAT IN THE SITUATION WHEREIN THERE WAS A SPILL, SOME OF THE CHEMOTHERAPY CAME INTO CONTACT WITH THE PATIENT¿S CLOTHING, SURROUNDINGS AND THE PATIENT¿S SPOUSE¿S SHOES. NO CHEMOTHERAPY CAME IN CONTACT OF THE HEALTHCARE PROVIDER. PROPER PERSONAL PROTECTIVE EQUIPMENT. WAS USED TO CLEAN UP SPILL. THE PATIENT AND THE HEALTHCARE PROVIDER WERE FINE AFTER THE INCIDENT. IT WAS FURTHER REPORTED THAT THERE WAS A POSSIBILITY OF HARM TO THE PATIENT. THIS IS THE THIRD OF FOUR OCCURRENCES.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873941 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ PORT AND OCCURRED ON AN UNSPECIFIED DATE. IT WAS REPORTED THE END USER NOTED AT LEAST 3-4 ISSUES WITH THE CHEMOLOCKS AND HAVE HAD A COUPLE OF SPILLS ACROSS INFUSION SITES. IT WAS ALSO REPORTED THAT THE FIRST COUPLE OF TIMES, IT WAS NOT KNOWN IF IT WAS THE INJECTOR OR THE PORT. IT WAS ALSO STATED THAT ONE BIG CHEMO SPILL THAT HAPPENED WHILE THE CHEMOTHERAPY WAS INFUSING. THE SET UP OF THE PRODUCT WAS BOTH PRODUCTS WERE PLACED ON TUBINGS PRIOR TO CONNECTING TO PATIENTS. THE ISSUE WAS DURING PATIENT USE. THE MEDICATION INVOLVED WAS PACLITAXEL/ TAXOL. IT WAS ALSO REPORTED THAT IN THE SITUATION WHEREIN THERE WAS A SPILL, SOME OF THE CHEMOTHERAPY CAME INTO CONTACT WITH THE PATIENT¿S CLOTHING, SURROUNDINGS AND THE PATIENT¿S SPOUSE¿S SHOES. NO CHEMOTHERAPY CAME IN CONTACT OF THE HEALTHCARE PROVIDER. PROPER PERSONAL PROTECTIVE EQUIPMENT. WAS USED TO CLEAN UP SPILL. THE PATIENT AND THE HEALTHCARE PROVIDER WERE FINE AFTER THE INCIDENT. IT WAS FURTHER REPORTED THAT THERE WAS A POSSIBILITY OF HARM TO THE PATIENT. THIS IS THE FORTH OF FOUR OCCURRENCES

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873939 ↗

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-0331-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• 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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• 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
• 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-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• 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

…and 44 more.