ICU Medical CL3955Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709082502), received between Feb 19, 2020 and May 16, 2025 — 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.

• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT. THE REPORTER STATED THAT WHEN NURSE DISCONNECTED THE CHEMO LOCK IV TUBING FROM MTX BAG, FLUID SPLASHED FROM THE CHEMO LOCK OUT INTO THE NURSES EYE DURING A PATIENT'S INFUSION. THERE WAS NO DRIPPING NOTED FROM IV TUBING OR MTX BAG AFTER RECONNECTION. MTX WAS FLUSHED WITH NO FURTHER ISSUES.

  Patient problems: Chemical Exposure

  MAUDE report 22040609 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT THAT EXPERIENCED LEAKAGE DURING PATIENT USE. IT WAS REPORTED THAT CHEMO BAG SPIKE FELL OFF, IMMEDIATE SPILL OF PACLITAXEL CHEMO STRAIGHT DOWN TO IV. THE DATE OF INCIDENT WAS ON 20-JAN-2025. THE REPORT WAS SUBMITTED TO MANUFACTURER (ICU MEDICAL) AND VENDOR (CARDINAL HEALTH) WITH VENDOR REFERENCE NUMBER (B)(4). THE PRODUCT WAS NOT RETURNED TO MANUFACTURER AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939373 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT THAT EXPERIENCED SEPARATION AND LEAKAGE DURING PATIENT USE. IT WAS REPORTED THAT CHEMO BAG SPIKE FELL OFF, IMMEDIATE SPILL OF PACLITAXEL CHEMO STRAIGHT DOWN TO IV. THE DATE OF INCIDENT WAS ON (B)(6) 2025. THE REPORT WAS SUBMITTED TO MANUFACTURER (ICU MEDICAL) AND VENDOR (B)(4) WITH VENDOR REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938810 ↗
• MalfunctionMar 14, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT. IT WAS REPORTED THAT THE PRODUCT WAS LEAKING AND SNAPPED AT THE BAG PORT WHEN ATTACHING THE CIRCLE PRIMING TUBING USING ITEM #CL3534 (5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP, ICU MEDICAL INC MANUFACTURER). THE CL3955 SNAPPED WHEN ATTACHING THE CL3534 TO THE CL3534 SIDE PORT. THE CUSTOMER WAS UNABLE TO SAFELY SAVE THE PRODUCT AS IT WAS CONTAMINATED WITH 100ML OF PACLITAXEL BUT THEY CAN PROVIDE A SAMPLE OF THE SAME LOT NUMBER OF CL3955 AND THE B BRAUN 100ML 0.9%NS PVC-FREE BAG. IT IS EXTREMELY UNSAFE FOR STAFF TO CLEAN THIS TUBING AND BAG. ALTHOUGH IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, THE CUSTOMER ALSO STATED THAT THE ISSUE WAS NOTICED DURING / AFTER USE AND THE PROBLEM FREQUENCY WAS ONGOING FOR MONTHS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21611307 ↗
• MalfunctionOct 28, 2020Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT, AND A 500 ML BAG OF CYTARABINE. THE NURSE HUNG THE BAG ON AN IV POLE TO START THE CIRCLE PRIMING PROCESS AND SQUEEZED THE DRIP CHAMBER. APPROXIMATELY 10 SECONDS LATER, THE BAG SPIKE DISLODGED FROM THE BAG, AND FELL TO THE FLOOR CAUSING CHEMOTHERAPY TO SPILL FROM THE OPENING. CHEMOTHERAPY PROCEEDED TO SPILL FROM THE NOW OPEN SPOUT OF THE BAG ONTO THE IV PUMP, AND FLOOR OF THE MED ROOM, AND SPLASHED ON THE SHOES AND PANT HEMS OF THE TWO NURSES STANDING NEARBY. BOTH REACTED QUICKLY, MOVING AWAY FROM THE SPILLING CHEMO, AND ONE WAS ABLE TO INVERT THE BAG TO STOP THE FLOW. A GREEN KELLY CLAMP WAS USED TO PINCH THE SPOUT CLOSED. THE NURSES WHO HAD CHEMO SPLASH ON THEIR SHOES AND PANTS REPORTED THAT, AS FAR AS THEY COULD TELL, NO CHEMO HAD DIRECTLY COME IN CONTACT WITH THEIR SKIN. THERE WAS NO PATIENT INVOLVEMENT AS THE DEVICE WAS NOT TAKEN TO THE PATIENT, THEREFORE, NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Patient Involvement

  MAUDE report 10750449 ↗
• MalfunctionFeb 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  SUS VOLUNTARY EVENT REPORT(B)(4) WAS RECEIVED ON (B)(6)2020 STATING "CSTD DROPPED OUT OF CHEMOTHERAPY INFUSION BAG AS THE NURSE WAS HANGING THE BAG TO START INFUSION. BOTH THE PATIENT AND NURSE WERE EXPOSED. THE INFUSION OF CHEMOTHERAPY (CARBOPLATIN) WAS CLOSED USING THE ICU MEDICAL CSTD, CHEMOLOCK UNTIL THE CL-3955 FELL OUT OF THE BAG RESULTING IN APPROXIMATELY 50ML OF HAZARDOUS SOLUTION FALLING ON THE NURSE, PATIENT, PATIENT'S CHAIR AND THE FLOOR WHERE THE NURSE WAS STANDING. THE NURSE WAS ABLE TO INSERT THE SPIKE BACK INTO THE BAG TO STOP FLOW. THE BAG/TUBING WAS CONTAINED IN CHEMO ZIP LOCK BAG THEN RETURNED TO THE PHARMACY FOR BLACK BUCKET BULK CHEMO WASTE DISPOSAL. THE PHARMACY COMPOUNDED A SECOND BAG FOR TREATMENT OF THE PATIENT."

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

  MAUDE report 9729021 ↗

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-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0359-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• 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-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-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• Z-0352-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

…and 44 more.