ICU Medical CL3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709057029), received between Oct 31, 2023 and May 13, 2025 — classified as 6 malfunctions.

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

3 FDA recall records name this device's identifier, 3 still open.

57 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. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3161-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 8, 2025Class IIOpen, Classified

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

   Z-0333-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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.

• MalfunctionMay 13, 2025Particulates; Particulates

  THE COMPLAINT/EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHAMBER, CHEMOLOCK® W/RED CAP, BAG HANGER. FLOATERS (LIKE SMALL HAIRS OR FABRIC PIECES) IN THE "SQUEEZING BULB" OF THE ADULT TUBING WERE OBSERVED AND CONFIRMED BY TWO STAFF MEMBERS. THIS WAS DISCOVERED DURING THE PHARMACIST'S FINAL MEDICATION CHECK (OF AN UNKNOWN DRUG) BEFORE HANDING OFF TO NURSING FOR ADMINISTRATION. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT/HARM AND THERE WAS A SMALL DELAY IN THERAPY AS THE DOSE NEEDED TO BE REMADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008731 ↗
• MalfunctionMay 12, 2025Particulates; Particulates

  THE COMPLAINT/EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHAMBER, CHEMOLOCK® W/RED CAP, BAG HANGER. SAND-LIKE FLOATERS IN THE "SQUEEZING BULB" OF THE ADULT TUBING WERE OBSERVED AND CONFIRMED BY TWO STAFF MEMBERS. THIS WAS DISCOVERED DURING THE PHARMACIST'S FINAL MEDICATION CHECK (OF THE UNKNOWN DRUG) BEFORE HANDING OFF TO NURSING FOR ADMINISTRATION. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT/HARM AND THERE WAS A SMALL DELAY IN THERAPY AS REPLACEMENT LINE WITH A DIFFERENT LOT WAS PROCURED AND THE DOSE WAS REMADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007020 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHAMBER, CHEMOLOCK® W/RED CAP, BAG HANGER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THE RITUXAN TUBING SET WAS LEAKING AT THE JUNCTION. THE PATIENT REPORTED WHILE THE INFUSION WAS GOING ON. ABOUT 300 ML INFUSED. THE NURSE REPORTED ABOUT 30ML LEAKED. THE TUBING SET WAS EXCHANGED AND INFUSION RESTARTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543170 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHAMBER, CHEMOLOCK® W/RED CAP, BAG HANGER. A LEAK WAS OBSERVED TO BE DRIPPING FROM THE CONNECTION OF THE TUBING WITH THE CLOSED SYSTEM TRANSFER DEVICE (CSTD) FROM THE PREPACKAGED TUBING THAT THE PHARMACY USES. THERE WERE ONLY SEVERAL DROPS OF UNSPECIFIED CHEMOTHERAPY IN THE PLASTIC BAG BEFORE ADMINISTRATION. THERE WERE NO OBVIOUS DEFECTS SUCH AS ANY CRACKS OR BREAKS ON THE TUBING SET. THE LEAK DID NOT COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THERE WAS NO HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944101 ↗
• MalfunctionMar 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, CHEMOLOCK¿ W/RED CAP, BAG HANGER WHERE THE CUSTOMER REPORTED THAT THE DEICE WAS LEAKING MEDICATION (UNSPECIFIED) FROM A CHEMO LOCK CONNECTOR WHILE BEING ADMINISTERED TO THE PATIENT. THERE WERE DRIPS OF THE MEDICINE ON A SMALL PART ON THE FLOOR. THERE WAS NO HUMAN HARM, NO UNPROTECTED CHEMO EXPOSURE TO PATIENT OR HEALTHCARE PROVIDER SINCE IT WAS SPILLED ONTO THE FLOOR AND WAS CLEANED RIGHT AWAY. IT WAS FURTHER STATED THAT THE HEALTHCARE PROVIDER WAS WEARING PPE DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888659 ↗
• MalfunctionOct 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINT EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHAMBER, CHEMOLOCK® W/RED CAP, BAG HANGER. A COMPOUNDING TECHNICIAN AT THE FACILITY REPORTED THAT A SMALL PIECE OF HAIR WAS FLOATING IN THE DRIP CHAMBER OF A SECONDARY SET CHEMOLOCK AFTER SPIKING AND CIRCLE PRIMING WITH AN ICU MEDICAL D5W 500ML IV BAG. THE HAIR WAS REPORTED TO BE IN ONE PIECE, BROWN, AN INCH LONG, AND THIN. THE PRODUCT WAS SEALED AND WAS STORED IN CLEAN BUNS. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041234 ↗

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-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-0349-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• Z-0364-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• Z-0344-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• 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-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-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• Z-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• 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-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-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-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10

…and 42 more.