Alaris, SmartSite, Texium 22601-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, 196 cm (77 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403240966), received between Sep 6, 2019 and Sep 6, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
1 FDA recall record name this device's identifier, 1 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
- 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
- Fluid/Blood Leak4
Patient problems
- No Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CHEMOTHERAPY LEAK WHERE THE BONDED CLOSED SYSTEM NEEDLELESS VALVE WAS ATTACHED TO THE TUBING WHICH RESULTED IN A SPILL.
Patient problems: No Information
MAUDE report 8972222 ↗MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CHEMOTHERAPY LEAK WHERE THE BONDED CLOSED SYSTEM NEEDLELESS VALVE WAS ATTACHED TO THE TUBING.
Patient problems: No Information
MAUDE report 8971766 ↗MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CHEMOTHERAPY LEAK WHERE THE BONDED CLOSED SYSTEM NEEDLELESS VALVE WAS ATTACHED TO THE TUBING.
Patient problems: No Information
MAUDE report 8971764 ↗MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CHEMOTHERAPY LEAK WHERE THE BONDED TEXIUM WAS ATTACHED TO THE TUBING WHICH RESULTED IN A SPILL.
Patient problems: No Information
MAUDE report 8971501 ↗
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- 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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