ICU Medical CL3528Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709057043), received between Mar 7, 2025 and Feb 25, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Air/Gas in Device

  EVENT OCCURRED REGARDING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK W/RED CAP, HANGER WHERE IT WAS REPORTED THAT FILTER SET DRAWING AIR POST FILTER FOR AN INFUSION AFTER IT HAD BEEN RUNNING FOR 3 HOURS. THIS EVENT OCCURRED DURING HOUR 3 OF ADMINISTRATION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444807 ↗
• MalfunctionJan 12, 2026Air/Gas in Device

  THE EVENT INVOLVED A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK W/RED CAP, HANGER WHERE IT WAS REPORTED THAT AN EXTENDED INFUSION PULLED AIR POST FILTER. THE EVENT OCCURRED 20 HOURS INTO THE INFUSION. PATIENT WAS NOT ABLE TO GET THEIR FULL DOSE OF THE MEDICATION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038723 ↗
• MalfunctionDec 11, 2025Air/Gas in Device; Air/Gas in Device

  AN INCIDENT INVOLVING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK W/RED CAP, HANGER 1 OF 2 EVENTS REPORTED THAT FILTER SETS DRAWING AIR POST FILTER GREATER THAN 8 HOURS AFTER THE INFUSION HAS BEEN STARTED ON SOME OF THEIR EXTENDED INFUSIONS. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786125 ↗
• MalfunctionDec 11, 2025Air/Gas in Device; Air/Gas in Device

  AN INCIDENT INVOLVING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK W/RED CAP, HANGER 1 OF 2 EVENTS REPORTED THAT FILTER SETS DRAWING AIR POST FILTER GREATER THAN 8 HOURS AFTER THE INFUSION HAS BEEN STARTED ON SOME OF THEIR EXTENDED INFUSIONS. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786122 ↗
• MalfunctionSep 9, 2025Air/Gas in Device; Air/Gas in Device

  EVENT OCCURRED REGARDING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK¿ W/RED CAP, HANGER WHERE THE REPORTER STATED THAT "THERE WERE TWO INSTANCES OF AIR BUBBLE FORMING IN THE LINE BETWEEN THE FILTER AND DISTAL END OF THE LINE ATTACHED TO THE B PORT ON THE PLUM 360 DEDICATED SET DURING INFUSION. NO SPILLS WITH EITHER EVENT. DOSES WERE REMADE. THERE WAS CHEMO AND BIOZARD INVOLVED." THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS DELAY IN THERAPY. THE MEDICATION USED ON THE EVENT WAS ETOPOSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000006 ↗
• MalfunctionAug 27, 2025Separation Problem; Separation Problem

  EVENT OCCURRED REGARDING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK¿ W/RED CAP, HANGER WHERE THE REPORTER STATED "THAT 6 HOURS AFTER THE INFUSION STARTS, BUBBLES POST FILTER CAUSED A PUMP ERROR AND WHEN THE NURSE WAS ADDRESSING THE PUMP ERROR, THE LINE FELL OUT OF THE BAG. THE NURSE WAS EXPOSED TO 450 ML OF ETOPOSIDE, DOXORUBICIN, VINCRISTINE MIXTURE. THERE WERE PATIENT INVOLVEMENT AND DELAY IN THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 22909568 ↗
• MalfunctionAug 25, 2025Separation Problem; Air/Gas in Device; Separation Problem; Air/Gas in Device

  EVENT OCCURRED REGARDING A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK¿ W/RED CAP, HANGER WHERE THE REPORTER STATED THAT "AN IV PUMP WAS RUNNING PATIENT¿S CHEMO, AND EPOCH (DOXORUBICIN, ETOPOSIDE, & VINCRISTINE) WAS BEEPING WITH "AIR IN LINE" MESSAGE. CSL WENT INTO ROOM TO CHECK AND FOUND AIR BUBBLE IN SECONDARY TUBING PAST THE FILTER. CSL CONNECTED THE BLUE CHEMO PORT LOCKS TOGETHER IN ORDER TO CYCLE OUT THE AIR BUBBLE. WHEN CSL REACHED UP TO DISCONNECT THE CHEMO PORT LOCKS ON THE SECONDARY IV TUBING, THE ENTIRE SECONDARY TUBING SET FELL OUT OF THE CHEMO BAG WHERE IT WAS SPIKED." THE 3/4 FULL BAG OF EPOCH WAS DRAINED FROM BAG HANGING ON TOP OF IV POLE. THEY ALSO REPORTED EARLIER EVENT WHERE IV PUMP SHOWED "AIR IN LINE" ERROR MULTIPLE TIMES REQUIRING FREQUENT UNTWISTING AND OPENING IV PUMP LEVER IN ORDER TO RESOLVE AIR BUBBLE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND UNKNOWN DELAY IN CRITICAL THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883553 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK¿ W/RED CAP, HANGER WAS FOUND TO HAVE GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THE KEYTRUDA TUBING SET WAS LEAKING AT THE JUNCTION WITH CL2000S. THE TUBING SET WAS EXCHANGED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549075 ↗

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-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-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• 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-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• 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-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-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0331-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• 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-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

…and 44 more.