ICU Medical CL3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00887709057012), received between Aug 29, 2017 and Sep 16, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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-0332-2026 · 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793108 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT DURING USE, IT APPEARED THAT THE PLASTIC SPIKE OF THE INFUSION SET DID NOT CREATE A SECURE ENOUGH CONNECTION INSIDE THE 50 ML NS BAG, DESPITE BEING INSERTED COMPLETELY. ULTIMATELY, THE PLASTIC SPIKE OF THE INFUSION SET SLID OUT OF THE OUTLET PORT WHILE HANGING ON THE INFUSION POLE, RESULTING IN A HAZARDOUS DRUG SPILL. ONE OF THEIR NURSES WAS EXPOSED TO THE CHEMOTHERAPY COMPOUND AND HAD TO GO TO OCCUPATIONAL HEALTH FOR EVALUATION AND SUBSEQUENTLY TOOK TIME OFF FROM WORK. NO INFORMATION REGARDING MEDICAL INTERVENTION WAS PROVIDED. THERE WAS NO REPORT OF HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 24523751 ↗
• MalfunctionDec 10, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MDR REPORT#: MW5178964 WAS RECEIVED REGARDING A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. THE REPORT STATED THAT THE RN RECEIVED PREPARED MEDICATION (ACTEMRA) FOR OUTPATIENT PHARMACY. THE MEDICATION WAS DELIVERED AS PER USUAL, IN A SEPARATE BAG WITH THE IV BAG ALREADY SPIKED AND PRIMED WITH SECONDARY IV SET TUBING. THE RN REMOVED THE MEDICATION FROM THE BAG ALREADY SPIKED AND PRIMED WITH SECONDARY IV SET TUBING AND HUNG IT UP ON THE IV POLE, REMOVED THE RED CAP TO ATTACH TO THE PATIENT'S PRIMARY TUBING FOR ADMINISTRATION AND THE UNIVERSAL SPIKE FROM THE SECONDARY IV SET JUST FELL OUT FROM THE ATTACHMENT SITE OF THE SECONDARY BAG OF ACTEMRA, RESULTING IN THE MEDICATION BEGIN SPILLED. NO PATIENTS OR STAFF WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774602 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  MDR REPORT # MW5178965 WAS RECEIVED REGARDING A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. THE REPORT STATED THAT THE RN RECEIVED PREPARED MEDICATION (ACTEMRA) FOR OUTPATIENT PHARMACY. THE MEDICATION WAS DELIVERED AS PER USUAL, IN A SEPARATE BAG WITH THE IV BAG ALREADY SPIKED AND PRIMED WITH SECONDARY IV SET TUBING. THE RN REMOVED THE MEDICATION FROM THE BAG ALREADY SPIKED AND PRIMED WITH SECONDARY IV SET TUBING AND HUNG IT UP ON THE IV POLE, REMOVED THE RED CAP TO ATTACH TO THE PATIENT'S PRIMARY TUBING FOR ADMINISTRATION AND THE UNIVERSAL SPIKE FROM THE SECONDARY IV SET JUST FELL OUT FROM THE ATTACHMENT SITE OF THE SECONDARY BAG OF ACTEMRA, RESULTING IN THE MEDICATION BEGIN SPILLED. MANAGER FOLLOW UP COMMENTS: ON 8/29/2025 THE RN AGREED WITH THE ASSESSMENT OF SPIKE INSERT POTENTIALLY MAKING THE INSERTION HOLE NOT AS STRONG. THIS IS THE FIRST TIME THEY HAVE ENCOUNTERED THIS ISSUE AND WANTED TO RAISE AWARENESS ACROSS THE PHARMACY JUST FOR A 2ND CHECK ON THAT SPIKE BEING SECURE IN THE FUTURE WOULD BE USEFUL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774397 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN APRIL 2025 AND INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. IT WAS REPORTED THE REGISTERED NURSE (RN) HUNG DECITABINE ON LINE B, AS SOON AS PUSHED START ON THE PLUM PUMP, FLUID NOTED LEAKING OUT AT SPINNING SPIROS ON THE DECTIABINE SECONDARY LINE, THAT CAME FROM THE PHARMACY. THIS LINE HAD BEEN PRIMED WITH SALINE AT THE PHARMACY AND RN WAS AT THE CHAIRSIDE, IMMEDIATELY TURNED OFF THE PUMP AND CLAMPED THE SECONDARY LINE. DECITABINE WAS RETURNED TO THE PHARMACY. PHARMACY DID NOT HAVE TO WASTE THE BAG; THEY RETURNED THE BAG WITH NEW SECONDARY TUBING. PRIMARY TUBING WAS CHANGED SINCE HIGH LIKELIHOOD OF PROXIMAL OCCLUSION. THERE IS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364404 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPIRO WHERE IT WAS REPORTED THE DEVICE LEAKED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055287 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH. FLUID REPORTEDLY BEGAN LEAKING AROUND THE SPINNING SPIROS ON THE SECONDARY LINE AS SOON AS THE RN PUSHED START ON THE PLUM PUMP DURING A PATIENT'S INFUSION. THE NURSE SET UP FOR THE INFUSION AS FOLLOWS: LEUCOVORIN WAS HUNG, ATTACHED SECONDARY TUBING (FROM THE PHARMACY) TO THE CLAVE ON THE PRIMARY LINE. THE RN CLOSED THE CLAMPS ON THE SECONDARY LINE AND TURNED OFF THE PUMP. THE PHARMACIST, NICK, WAS INFORMED AND THE BAG AND DEVICE WERE RETURNED TO THE PHARMACY. PHARMACY CHANGED OUT THE SECONDARY TUBING AND RETURNED THE BAG; THE BAG DID NOT HAVE TO BE REMADE OR WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039064 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. FLUID WAS REPORTEDLY LEAKING NEAR THE SPINNING SPIROS ON THE SECONDARY LINE. THE NURSE HUNG CYTOXAN AS AN ATTACHED SECONDARY CYTOXAN LINE (FROM THE PHARMACY) TO THE B LINE AND TURNED ON THE PLUM PUMP WHEN THE LEAKAGE WAS NOTED. THE SECONDARY LINE HAD BEEN PRIMED WITH NORMAL SALINE BY THE PHARMACY. THE RN WAS AT CHAIRSIDE AND CLOSED THE CLAMPS, TURNED OFF THE PUMP AND RETURNED THE CYTOXAN BAG TO THE PHARMACY. THE PHARMACY DID NOT NEED TO WASTE THE MED. THEY RETURNED THE BAG WITH NEW SECONDARY TUBING. THE RN CHANGED OUT THE PRIMARY LINE AS SHE WAS CONCERNED OF A HIGH LIKELIHOOD OF PROXIMAL OCCLUSION. A MEDSUN MANDATORY AND VOLUNTARY WITH UF/IMPORTER REPORT NUMBER 1275899072-2025-8042 WAS RECEIVED ON 09-MAY-2025, FROM (B)(6) A HEALTH PROFESSIONAL RISK MANAGER OF SCRIPPS CLINICS STATING THAT THE TYPE OF REPORT WAS A MALFUNCTION PRODUCT PROBLEM. THIS IS NOT A LABORATORY TEST DEVICE, AND IT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THE COMMON DEVICE NAME WAS CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM WITH PROCODE ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038349 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT HAZARDOUS DRUG LEAKS ASSOCIATED WITH THE ICU MEDICAL TUBING. THE LEAKING WAS BELIEVED TO HAVE OCCURRED AT EITHER SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981723 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT HAZARDOUS DRUG LEAKS ASSOCIATED WITH THE ICU MEDICAL TUBING. THE LEAKING WAS BELIEVED TO HAVE OCCURRED AT EITHER SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THE TWO EVENTS THAT OCCURRED ON THIS DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981708 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT HAZARDOUS DRUG LEAKS ASSOCIATED WITH THE ICU MEDICAL TUBING. THE LEAKING WAS BELIEVED TO HAVE OCCURRED AT EITHER SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981702 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT HAZARDOUS DRUG LEAKS ASSOCIATED WITH THE ICU MEDICAL TUBING. THE LEAKING WAS BELIEVED TO HAVE OCCURRED AT EITHER SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981664 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT THE HAZARDOUS DRUG (UNSPECIFIED) LEAKED DURING PATIENT USE. THE LEAK WAS EITHER AT THE SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. THERE WAS APPARENTLY 5 SIMILAR INCIDENTS FROM THIS FACILITY, DATES UNSPECIFIED. ALL INCIDENTS INVOLVE LEAKING OR OCCLUDED/ALARMING SPIROS. THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972825 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT A HAZARDOUS DRUG LEAKED DURING PATIENT USE. THE CUSTOMER STATED THAT THE LEAK WAS EITHER AT SPIROS ON THE SECONDARY TUBING OR THE MICROCLAVE ON THE PRIMARY TUBING. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972087 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS UNSPECIFIED DATES AND INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE IT WAS REPORTED THAT THEY HAD HAZARDOUS DRUG LEAKS FOR THE PAST MONTH. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HUMAN HARM. THE CUSTOMER STATED THERE WERE 10 OCCURRENCES FOR LOT NUMBER 14114306.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546952 ↗
• MalfunctionAug 23, 2024Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. IT WAS REPORTED THAT DURING AN INFUSION OF HAZARDOUS MEDICATION. THE INFUSION WAS SUPPOSED TO BE RAN FOR 2 HOURS BUT HALF THE BAG WAS INFUSED IN JUST OVER 20 MINUTES. INFUSION WAS STOPPED, PATIENT WAS ASSESSED, AND INFUSION PUMP WAS CHECKED AS WELL. THE INFUSION PUMP WAS CHANGED, AND THE RESULT WAS THE INFUSION WAS STILL RUNNING AT AN ACCELERATED RATE. PATIENT WAS NOT HARMED AT ALL THROUGHOUT THE RUN TIME OF THE INFUSION. THERE WERE OTHER INFUSIONS THAT USED THIS SPECIFIC LOT, AND EVERYTHING CAME OUT AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050507 ↗
• MalfunctionJun 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE LOT NUMBER 13850282. THE EVENT OCCURRED DURING PATIENT INFUSION. NO PATIENT HARM AND SLIGHT DELAY OF THERAPY DUE TO BAG HAD TO BE REMADE BY PHARMACY. MEDICATION LEAKED FROM SPINNING SPIROS ON 2NDARY TUBING. THE MEDICATION TO BE HUNG WAS GEMZAR. THE NURSE CAUGHT IT WHILE WAS JUST A FEW DROPS, MOST LIKELY WAS SALINE THAT TUBING HAD BEEN PRIMED WITH, NURSE CHANGED OUT PRIMARY TUBING FIRST WHEN NOTICED A PROBLEM, THEN WHEN UNCLAMPED SECONDARY TUBING, LEAKING NOTED AT SPINNING SPIROS. BAG AND TUBING TAKEN OUT OF SERVICE AND PHARMACY MADE A NEW BAG WITH NEW TUBING. FURTHER INFORMATION WAS PROVIDED VIA UF/ IMPORTER REPORT NUMBER (B)(4) STATING THAT THE PATIENT RECEIVED DOSE WITHOUT FURTHER PROBLEM. THE TUBING WAS PRIMED WITH SALINE BUT IT IS UNKNOWN IF ANY CHEMO LEAKED OUT, THE PHARMACIST AND NURSE SURMISE SINCE TUBING IS PRIMED WITH SALINE IT MAY HAVE BEEN THE SALINE THAT LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538586 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. LEAKAGE WAS REPORTED AT THE CONNECTION POINT BETWEEN THE SPIROS AND THE TUBING DURING INFUSION. THE CUSTOMER STATED THAT THE LEAK WAS DUE TO THE TUBING FAILING OR CRACKING. THE SET-UP WAS REPLACED AND THERAPY RESUMED. THERE WAS NO HARM TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT ISSUE. THIS REPORT REFLECTS 5 SAME/SIMILAR INSTANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381934 ↗
• MalfunctionMay 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHERE THE CUSTOMER REPORTED THAT THERE WAS LEAKAGE FROM CONNECTION POINT BETWEEN THE SPIROS AND THE TUBING. THE CUSTOMER STATED THAT THE TUBING WAS FAILING OR CRACKING. THE ISSUE WAS DISCOVERED DURING INFUSION. THE SET-UP WAS THEN REPLACED AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HARM ASSOCIATED WITH THE EVENT. THERE WERE 7 INCIDENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377553 ↗
• MalfunctionJan 17, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER WHICH WAS RECEIVED VIA A MEDWATCH VOLUNTARY MDR REPORT # MW5148558. THE MEDWATCH STATED " CHEMOLOCK DRIP CHAMBER- THE CLOSED SYSTEM TRANSFER DEVICE CTSD, WHICH KEEPS CHEMO FROM SPILLING OUT THE END OF THE IV TUBING CAME DISCONNECTED FROM THE IV TUBING ALLOWING BOTH CHEMOTHERAPY TO SPILL FROM THE TUBING AND BLOOD TO LEAK OUT OF THE PORT SITE. THIS CONNECTOR IS MADE TO NOT BE ABLE TO REMOVE FROM THE IV TUBING AND WAS DETERMINED TO HAVE MALFUNCTIONED ALLOWING IT TO SEPARATE FROM THE TUBING." THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531158 ↗
• MalfunctionSep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER THAT HAD A CHEMO SPILL FROM THE SPIROS END ON THE TUBING. THE MEDICATION USED WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 10508301 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY MEDWATCH REPORT (#MW5095106) WAS RECEIVED AND STATED THAT A "SPIROS CLOSED SYSTEM TRANSFER DEVICE ON DOXORUBICIN SYRINGE LEAKED WHEN RN STARTED TO ADMINISTER TO PATIENT X 2. NEW DOSE SYRINGE AND SPIROS PROVIDED BY PHARMACY AND DOSE WAS ADMINISTERED WITHOUT LEAKING. ALSO HAD LEAKING SPIROS CHEMOLOCK SET.¿ THE PRODUCT INVOLVED WAS A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. THE ISSUES NOTED WERE FOUND TO BE LEAKING DURING PRIMING IN SOME INSTANCES BUT ALSO DURING ADMINISTRATION. IF NOTED DURING PRIMING, THE PRODUCT WAS REMADE PRIOR TO DISPENSING. THERE WERE NO COMPONENT DAMAGES OR ABNORMALITIES OBSERVED ON THE DEVICE. ADDITIONALLY, THE CUSTOMER REPORTED THE DEVICE WAS CONNECTED TO A BD ALARIS PUMP INFUSION SET (W/3 SMARTSITE Y-SITES) DURING ADMINISTRATION. THE MOST DISTAL Y-SITE WAS USED. NO HARM WAS REPORTED. THIS REPORT IS FOR THE SPIROS CHEMOLOCK SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396848 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY MEDWATCH REPORT (#MW5095106) WAS RECEIVED AND STATED THE CUSTOMER HAD A LEAKING SPIROS CHEMOLOCK SET OF AN UNSPECIFIED MEDICATION. THE PRODUCT INVOLVED WAS A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER. THE ISSUES NOTED WERE FOUND TO BE LEAKING DURING PRIMING IN SOME INSTANCES BUT ALSO DURING ADMINISTRATION. IF NOTED DURING PRIMING, THE PRODUCT WAS REMADE PRIOR TO DISPENSING. THERE WERE NO COMPONENT DAMAGES OR ABNORMALITIES OBSERVED ON THE DEVICE. NO HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395428 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER THAT CAME OUT OF THE 100ML/50ML BAG TOO EASILY AND SPILLED ON THE FLOOR. DURING REMOVAL OF THE BAG FROM THE CHEMO TRANSPORT BAG, THE CHEMO SPILLED ON THE FLOOR AND A CHEMO SPILL KIT WAS USED FOR THE AREA. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 8749397 ↗
• MalfunctionJun 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER, SPIROS® W/RED CAP, HANGER THAT WAS REPORTED AS THE TUBING WAS COMING OUT OF THE B BRAUN 100ML/50ML BAG TOO EASILY. DURING REMOVAL OF THE BAG FROM THE CHEMO TRANSPORT BAG THE CHEMO SPILLED ON THE FLOOR AND A CHEMO SPILL KIT WAS USED FOR THE AREA. THERE WAS NO PATIENT INVOLVED, NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 8723878 ↗

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-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• 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-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-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0329-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• Z-0365-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
• Z-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0344-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

…and 42 more.