Alaris, SmartSite, Texium 24601-B007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access Non-Vented, Low Sorbing Tubing (PE Lined) Bonded Closed Male Luer with Priming Cap, Back Check Valve, 2 Y-Sites, 300 cm (118 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the BD Alaris SmartSite Texium pump infusion set, tubing used to deliver IV drugs such as chemotherapy. The 33 reports mostly describe leaking or splashing at the tubing and connector sites, with drug spilling onto patients, clothing and bedding; no deaths and no injuries. Three open recalls cover performance data discrepancies, leaking at the closed connector interface, and labeling that said the sets were free of DEHP when they were not.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885403240959), received between Sep 26, 2018 and Jan 6, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (24 reports).
3 FDA recall records name this device's identifier, 3 still open.
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
Recalls naming this device
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
- May 12, 2025Class IIOpen, Classified
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Z-1970-2025 · Root cause: Process control · Recall details · FDA record ↗
- Oct 11, 2023Class IIOpen, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash24
- Defective Component2
- Fluid/Blood Leak2
- Air/Gas in Device1
- Break1
- Chemical Problem1
- Crack1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient3
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM LEAK WITH MULTIPLE TUBING SETS OF SAME LOT # WHILE ADMINISTERING CISPLATIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23979882 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKINGTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY THE CUSTOMER THAT WET SPOT ON HER SHIRT WHERE THE CHEMO TUBING CONNECTED TO HER PORT NEEDLE EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514195 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT PT HOOKED UP TO DOCETAXEL, PT CALLED WITH LEAKING ON HER SHIRT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513830 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT APPEARED TO HAVE BEEN LEAKING AT THE CONNECTION SITE OF THE BLUE NEEDLELESS CONNECTOR AND THE GREEN TEXIUM CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513617 ↗MalfunctionNov 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ETOPOSIDE LEAKED ONTO PATIENT- ROUGHLY 12 IN X 12 IN WET SPOT-ON PATIENT'S SHIRT. NO SKIN IRRITATION AT THIS TIME. PATIENT CLEANED UP AND CHANGED OUT OF SOILED CLOTHING. INSTRUCTED TO WASH SOILED CLOTHING SEPARATELY. PROVIDER NOTIFIED. PRIMARY TEXIUM TUBING REF 24601-B007T LOT 25025433 EXP 2/21/2028.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466889 ↗MalfunctionOct 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMASRTSITE TEXIUM PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE LEAKING CISPLATIN ON PATIENT FROM WHERE TEXIUM TUBING CONNECTS TO PT PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347788 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PATIENT HAD NOTICED HER VEST AND BLANKET WERE WET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334041 ↗MalfunctionOct 19, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE A MICROTEAR WAS DISCOVERED IN THE PART OF THE CHEMO TUBING THAT IS CLOSED INSIDE THE IV CHANNEL AND THERE WERE SEVERAL DROPS OF CHEMO DIRECTLY ON THE FLOOR BELOW THE PUMP AND CHEMO LEAKED INSIDE THE CHANNEL AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334006 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE CARBOPLATIN STARTED NOTICEABLY LEAKING AT 1447 OUT OF THE TEXIUM CAP AT THE END OF THE TUBING CONNECTED TO THE PORT NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334003 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE CHEMO TUBING APPEARED TO HAVE A SMALL LEAK AT THE END OF THE TUBING THAT CONNECTS TO THE TEXIUM GREEN CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333698 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT CONNECTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333678 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT CAP WAS LOOSE CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333675 ↗MalfunctionOct 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY HAD A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23275813 ↗MalfunctionOct 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAD A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23275811 ↗MalfunctionApr 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING WAS DUE TO THIS LUER LOCK CONNECTION BETWEEN TEXIUM TIP AND TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936956 ↗MalfunctionMar 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. PARKLAND HAS HAD ONGOING LEAKING TEXIUM SETS, PRIMARILY WITH DOXIRUBICIN AND OTHER HAZARDOUS DRUGS / CHEMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619152 ↗MalfunctionDec 5, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852479 ↗MalfunctionNov 18, 2024Break; Defective Component; Break; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20713910 ↗MalfunctionNov 18, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20709199 ↗MalfunctionNov 18, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20708200 ↗MalfunctionJan 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM WE HAVE EXPERIENCED ANOTHER INCIDENT OF PRECIPITATION IN THE LOW SORBING TEXIUM TUBING(24601-B007T) AS WELL AS THE 0.2 MICRON FILTER WITH TEXIUM(20350ET) DURING A 24 HOUR PACLITAXEL INFUSION. I DO NOT HAVE THE LOTS AVAILABLE TO ME, BUT ATTACHED ARE PHOTOS OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423405 ↗MalfunctionMar 9, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE WITH 2 BD ALARIS PUMP MODULE SMARTSITE TEXIUM LEAKAGE OCCURRED AT Y-SITE WHERE IV TUBING IS ATTACHED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING AIR LEAKAGE AT LOWEST Y-SITE (CLOSEST TO PATIENT) WHEN ADDITIONAL IV TUBING ATTACHED. TUBING REPLACED TWICE AND AIR LEAKAGE OCCURRED AT THE SAME LOCATION EACH TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519076 ↗MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM TUBING EXPANDED DURING THE CHEMOTHERAPY INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE "INFUSION SET STOPPED INFUSING". UPON INSPECTION, CLINICIAN NOTICED A BULGE IN THE TUBING AND PUMP WAS ALARMING OCCLUDED. NEW TUBING AND PUMP WERE SEQUESTERED, AND INFUSION FINISHED WITHOUT FURTHER INCIDENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM. DO YOU KNOW HOW LONG THE SET HAD BEEN IN USE BEFORE THE BULGE WAS DISCOVERED? IT WAS RUNNING FOR 12 HOURS WHEN THIS HAPPENED. HAD AN IV PUSH BEEN DELIVERED PRIOR TO THE BULGE BEING DISCOVERED? YES. CAN YOU PLEASE PROVIDE PROCEDURE INVOLVED AND DESCRIBED MEDICATION USED : INFUSING CHEMOTHERAPY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464903 ↗MalfunctionApr 27, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PUTTING TUBING INTO ALARIS PUMP. THE NURSE NOTICED A LEAK THROUGH THE PORTION OF TUBING THAT IS INSERTED INTO THE ALARIS PUMP. THE NURSE REMOVED THE TUBING WITH THE LEAK. THE NURSE OBTAINED NEW TUBING. MEDICATION ADMINISTERED. NO UNTOWARD PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219948 ↗MalfunctionApr 20, 2022Crack; Crack
IT WAS REPORTED BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISD-TUBING INFUSION SET-24601-B007T-CRACKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160592 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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