Alaris, SmartSite, Texium 10321213TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access, Non-Vented Bonded Closed Male Luer with priming cap 272 cm (107 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403228971), received between May 19, 2021 and May 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (1 report).
2 FDA recall records name this device's identifier, 2 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.
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 ↗
Most reported problems
Device problems
- Free or Unrestricted Flow1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE AS LVP SS BAG 20D TEX LEAKED WHEN THE SPIKE DISCONNECTED FROM THE IV FLUID BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ACCOUNT PREVIOUSLY REPORTED TWO BAGS LEAKING WHEN THE SPIKES DISCONNECTED FROM THE IV FLUID BAG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11853172 ↗MalfunctionMay 19, 2021Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT AS LVP SS BAG 20D TEX HAD AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10321213T, BATCH NO: UNKNOWN. IT WAS REPORTED THAT AIR BUBBLES WERE VISIBLE IN THE LOWER PORTION OF THE TUBING, AFTER PRIMING THE SET. VERBATIM: XXXX, PHARMACIST REPORTED SEEING VISIBLE AIR BUBBLES AFTER PRIMING IV SET. BUBBLES ARE NOTED IN THE LOWER PORTION OF THE TUBING THAT IS COILED. IV SET MAY BE PRIMED THE DAY BEFORE USE OR MORNING OF USE. XXXX STATED SHE'LL FLICK THE TUBING TO GET RID OF THE AIR BUBBLES AND NURSES WILL SEND THE TUBING BACK TO PHARMACY. XXXX STATED SHE'LL FLICK THE TUBING TO GET RID OF THE AIR BUBBLES AND NURSES WILL SEND THE TUBING BACK TO PHARMACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11849830 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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