ICU Medical CL2000SRecalls & reported problems
Icu Medical, Inc. · ChemoLock™ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00887709056992), received between Dec 7, 2018 and Feb 25, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).
60 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak17
- Disconnection9
- Material Separation1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Chemical Exposure8
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Disconnection
AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A CHEMOLOCK REPORTED THAT IT DISCONNECTS FOR 2 TIMES WHILE CONTINUOUS 4-DAY INFUSIONS. THIS REPORT CAPTURES TWO OF THE TWO INCIDENTS. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441444 ↗MalfunctionFeb 25, 2026Disconnection
AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A CHEMOLOCK REPORTED THAT IT DISCONNECTS FOR 2 TIMES WHILE CONTINUOUS 4-DAY INFUSIONS. THIS REPORT CAPTURES ONE OF THE TWO INCIDENTS. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441395 ↗MalfunctionFeb 5, 2026Fluid/Blood Leak
WHEN THE NURSE CHECKED THE PATIENT'S LINE, SHE REPORTED (UNSPECIFIED) CHEMOTHERAPY LEAKAGE FROM THE CHEMOLOCK COMPONENTS (OF A CHEMOLOCK¿ DEVICE) 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 24274136 ↗MalfunctionOct 29, 2025Material Separation; Material Separation
EVENT OCCURRED REGARDING A CHEMOLOCK WHERE IT WAS REPORTED THAT THERE WAS A CHEMOLOCK DETACHED FROM THE PRIMED LINE OF A CISPLATIN BAG. THERE WAS PATIENT INVOLVEMENT, AND THERE EXPOSURE TO STAFF. THERE WAS ALSO DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419645 ↗MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN EMAIL WAS RECEIVED WITH REGARDS TO A CHEMOLOCK ALLEGING THAT THE CHEMOLOCK PORT AT THE END OF THE LINE WAS LEAKING BETWEEN THE LINE AND CHEMOLOCK DEVICE ON AN UNKNOWN DATE. THE CHEMOLOCK WAS BONDED ON THE LINE AND SPINS FREELY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410043 ↗MalfunctionSep 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ WHERE IT WAS REPORTED THERE WAS A CONTINUOUS LEAK AT THE CONNECTION SITE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019492 ↗MalfunctionSep 10, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ WHERE IT WAS REPORTED THE PRIMARY LINE BECAME DISENGAGED LEADING TO "A PUDDLE" OF CHEMO SPILLING ONTO THE FLOOR COMBINED WITH BLOOD TRAVELING UP THE LINE DIRECTLY FROM THE PATIENTS PORT SITE. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018823 ↗MalfunctionSep 8, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK¿ IN THE ONCOLOGY INFUSION CLINIC AND OCCURRED DURING PREPARATION. IT WAS REPORTED THAT THE CL2000S IS BEING ATTACHED TO BD PRIMARY PUMP TUBING. THE INJECTOR IS ADDED TO THE TUBING; CLINICIAN CAN HEAR THE CRACK AND THEN THE INJECTOR SPINS FREELY INDICATING ATTACHED. THE INJECTOR THEN COMES LOOSE OR DISCONNECTS CAUSING LEAKS AND IN SOME CASES CHEMO SPILLS. THIS HAVE BEEN OCCURRING ON AND OFF FOR THE PAST 3 WEEKS. THERE WAS A CODE ORANGE: A HAZARDOUS MATERIAL SPILL OR RELEASE WHICH HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED AS A RESULT OF EVENT BUT THERE WAS CHEMO EXPOSURE TO CLINICIANS. THE EVENT RESULTED TO DELAY IN THERAPY. THERE WAS NO HUMAN HARM REPORTED.
Patient problems: Chemical Exposure
MAUDE report 22994272 ↗MalfunctionSep 8, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK¿ IN THE ONCOLOGY INFUSION CLINIC AND OCCURRED DURING PREPARATION. IT WAS REPORTED THAT THE CL2000S IS BEING ATTACHED TO BD PRIMARY PUMP TUBING. THE INJECTOR IS ADDED TO THE TUBING; CLINICIAN CAN HEAR THE CRACK AND THEN THE INJECTOR SPINS FREELY INDICATING ATTACHED. THE INJECTOR THEN COMES LOOSE OR DISCONNECTS CAUSING LEAKS AND IN SOME CASES CHEMO SPILLS. THIS HAVE BEEN OCCURRING ON AND OFF FOR THE PAST 3 WEEKS. THERE WAS A CODE ORANGE: A HAZARDOUS MATERIAL SPILL OR RELEASE WHICH HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED AS A RESULT OF EVENT BUT THERE WAS CHEMO EXPOSURE TO CLINICIANS. THE EVENT RESULTED TO DELAY IN THERAPY. THERE WAS NO HUMAN HARM REPORTED.
Patient problems: Chemical Exposure
MAUDE report 22994231 ↗MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ THAT EXPERIENCED LEAKAGE DURING USE. IT WAS STATED IN THE REPORT THAT WHILE THEY ARE PUSHING DOXORUBICIN, THEY NOTED DROPS ON GAUZE AFTER FEELING RESISTANCE. CHEMOLOCK WAS ENGAGED. LOOKED LIKE THE LEAK WAS COMING FROM CHEMOLOCK ADAPTOR THAT COMES ATTACHED TO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22800493 ↗MalfunctionJan 30, 2025Disconnection; Disconnection
IT WAS REPORTED THAT A CHEMO LOCK SYRINGE ADAPTER WAS FOUND TO HAVE DISCONNECTED DURING PATIENT USE. THE REPORT STATED THAT MTX INFUSION DISCONNECTED AT THE CHEMO LOCK (IV TUBING DISCONNECTED FROM CHEMO LOCK AD, BOTH CHEMO LOCKS REMAINED CONNECTED TO THE PATIENT). 10 ML WAS ESTIMATED TO BE LOST IN THE BED/SHEETS AND SOME DIRECT CONTACT WITH THE PATIENT. THE PATIENT SHOWERED AT THE TIME OF DISCOVERY AND THE SKIN WAS WELL CLEANSED, NO DOCUMENTATION OF LOCAL REACTION TO CONTACT WITH CHEMO, AND APPROXIMATELY 30ML OF CHEMO WAS LOST IN THE INTRAVENOUS (IV) TUBING WHEN RE-CIRCLE PRIMED, WITH TOTAL DRUG LOSS OF APPROXIMATELY 40 ML. TOTAL BAG VOLUME IS 416 ML, LESS THAN 10% LOSS SO NO ADDITIONAL INTERVENTIONS. THE EVENT HAPPENED AT HAEMATOLOGY/ ONCOLOGY (5D ROOM# 7). THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21280315 ↗MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK¿ WHERE THE CUSTOMER REPORTED A LEAK. WHEN THE ETOPOSIDE WAS COMPLETED, AND THE LINE FLUSHED, MESNA PIGGYBACK 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 THE LOCK WAS TWISTED, IT WAS A LITTLE LOOSE. CHECKED THE PATIENT¿S SKIN AND IT WASN'T WET, NO RASH, REDNESS OF IRRITATION. THEY PAGED AN MD 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 20694943 ↗MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE COMPLAINT/EVENT INVOLVED A CHEMOLOCK¿ THAT REPORTEDLY LEAKED DOXORUBICIN LEAKED FROM THE PORT AREA OF THE DEVICE DURING PATIENT USE. THE PATIENT HAD SOME DOXORUBICIN FROM THE SYRINGE BEFORE IT LEAKED ALL OVER THE BLUE PAD. THE CUSTOMER REPORTED THAT THE LEVEL OF HARM WAS N/A OR NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533675 ↗MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CHEMOLOCK 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 20474584 ↗MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING AN UNSPECIFIED CHEMOLOCK WHERE THE CUSTOMER REPORTED THAT IMFINZI LEAKED AROUND THE CHEMOLOCK ADAPTER BUT WERE ABLE TO GET THE FULL DOSE OUT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293123 ↗MalfunctionSep 20, 2024Particulates; Particulates
A COMPLAINT WAS RECEIVED WITH REGARDS TO CHEMOLOCK¿ 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 20271849 ↗MalfunctionFeb 9, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK¿ INJECTOR THAT HAD A CHEMOTHERAPY, PACLITAXEL (TAXOL), SPILL DURING INFUSION, AND IT CAME IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE CLEAR PLASTIC PART OF THE CHEMOLOCK THAT CONNECTS TO THE IV TUBING, BECAME UNATTACHED AND THAT THE TUBING CAN UNSCREW FROM THE CHEMOLOCK. FURTHERMORE, IT WAS NOT A USER ERROR AS THEY WERE ABLE TO REPLICATE IT 4 TIMES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED, AND NO MEDICAL INTERVENTIONS REQUIRED.
Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions
MAUDE report 16335455 ↗MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK THAT DID NOT CONNECT TO THE NURSING PORT CAUSING A LEAK OF CHEMOTHERAPY. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.
Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions
MAUDE report 14567433 ↗MalfunctionFeb 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK THAT THE CUSTOMER REPORTED AT 1:30 PM THE PATIENT NOTICED DRIPS/LEAKAGE AROUND THE AREA WHERE IT INFUSES. THE UNSPECIFIED CHEMOTHERAPY, IN A 250 ML BAG, APPEARED TO BE LEAKING AT THE CONNECTION OF CL2000S AND CL2100 AT THE END OF THE TUBING. THE CHEMOTHERAPY CAME INTO CONTACT WITH THE PATIENT AND THEY TOOK ACTION. THE REMAINING 22 ML OF CHEMOTHERAPY WAS BROUGHT BACK TO THE PHARMACY AND THEY DREW UP THE REMAINING CHEMOTHERAPY FROM THE BAG IN A SYRINGE TO ADMINISTER TO THE PATIENT. THERE WAS SOME DELAY IN DELIVERING CHEMOTHERAPY AND THE CHEMOTHERAPY SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO BLOOD LOSS AND THERE WERE NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT NOR ANYONE HARMED AS A RESULT OF THE REPORTED EVENT.
Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions
MAUDE report 11380652 ↗MalfunctionOct 29, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK THAT THE CUSTOMER REPORTED THE CHEMO LINE WAS APART, AND CISPLATIN WAS FREE FLOWING IN THE BED. THE CUSTOMER STATED THE PATIENT RANG THE BELL, AND THE PATIENT'S IV LINE WAS APART FROM THE CHEMOLOCK PORT ON THE EXTENSION SET AT THE LUER END. THE "MOM" WAS HOLDING THE CHEMO LINE SO NOT TO EXPOSE THE LINE TO THE ENVIRONMENT. THE CHEMOTHERAPY DID NOT DIRECTLY COME INTO CONTACT WITH EITHER THE PATIENT OR THE NURSE, BUT THERE WAS SIGNIFICANT RISK OF EXPOSURE DUE TO THE OPEN, AND SPILLED CHEMO. THERE WAS PATIENT INVOLVEMENT OF A (B)(6) YEAR OLD PATIENT, AND NO ADVERSE EVENT WAS REPORTED.
Patient problems: Chemical Exposure; No Consequences Or Impact To Patient
MAUDE report 10754075 ↗MalfunctionOct 9, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOLOCK THAT THE CUSTOMER REPORTED WHEN THEY WENT TO CHECK ON A PATIENT TO COMPLETE THEIR ASSESSMENT IT WAS DISCOVERED A LINE UNATTACHED FROM THE PATIENT. THE UNSPECIFIED CHEMOTHERAPY WAS INFUSING FREELY INTO THE BED. THE CHEMOTHERAPY POSSIBLY WAS ON THE PATIENT, BUT IT WAS NOT ON THE HEALTHCARE PROVIDER. THE CUSTOMER REPORTED THE CHEMOLOCK CAP WAS NO LONGER ATTACHED TO THE IV LINE AND WAS ALSO NO LONGER ATTACHED TO THE PATIENT'S QUADFUSE EXTENSION SET. THE WHOLE LINE HAD TO BE CHANGED AND THE LINE'S WORTH OF CHEMOTHERAPY WAS LOST. THERE WAS NO PHYSICAL DEFECT NOTED ON THE CAP AND THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS PATIENT INVOLVEMENT AND MINIMUM HARM TO THE PATIENT WAS REPORTED BECAUSE OF THE DELAY IN CHEMOTHERAPY. THERE WAS NO BLOOD LOSS OR BLEED BACK.
Patient problems: Chemical Exposure; No Consequences Or Impact To Patient
MAUDE report 10656061 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
STAFF ATTACHED THE SET UP TO THE CHEMOLOCK EXTENSION PORT WHICH WAS ATTACHED TO THE PATIENTS PRIMARY TUBING (ALARIS NON-DHEP). A LEAK OF EPIRUBICIN FROM THE CENTER OF CHEMO LOCK CONNECTOR BETWEEN SYRINGE AND A PORT WAS NOTED BY THE NURSE. A SMALL AMOUNT OF DRUG TRICKLED DOWN PATIENT¿S ARM, BUT STAYED CONTAINED TO BLUE PAD AND THE ARM WAS CLEANED AS PER SKIN CARE GUIDELINES. THERE WERE NO CONCERNS WITH PATIENT¿S SKIN. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.
Patient problems: Chemical Exposure
MAUDE report 8143255 ↗
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, ClassifiedOncology sets with drip chambers
- Z-3161-2026 · May 12, 2026 · Open, ClassifiedIV Sets with drip chambers
- Z-2210-2026 · Mar 24, 2026 · Open, ClassifiedOncology 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-0358-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
- Z-0347-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
- Z-0356-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
- Z-0337-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
- Z-0330-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
- Z-0339-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
- Z-0335-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
- Z-0334-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
- Z-0353-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
- Z-0336-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
- Z-0350-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Port REF: CL2100
- Z-0363-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
…and 45 more.
Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices
- BD PhaSeal 515003BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page