Alaris, SmartSite 2403-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Half Set, Y-Site 220 cm (87 in) · Class 2
All models of Alaris, SmartSite (160)
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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403232473), received between Jul 8, 2021 and Jul 8, 2021 — classified as 1 malfunction.
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
- Jul 8, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2180-2025 · Root cause: Under Investigation by firm · 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
- Free or Unrestricted Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2021Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT THE AS LVP HALF SS HAD AIR BUBBLES IN THE LINE WHILE INFUSING BLINATUMOMAB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN CALLED UNIT QI NURSE AND EDUCATOR INTO PT ROOM DUE TO PUMP ALARMING " AIR IN LINE". PT WAS INFUSING BLINATUMOMAB THROUGHT CURLIN TUBING CONNECTED TO AN ALARIS 1/2 SET. PER RN, PUMP HAD BEEN BEEPING FREQUENTLY SINCE LAST EVENING. ON INSPECTION OF THE TUBING, A FEW BUBBLES WERE SEEN BELOW THE ALARIS PUMP AND ONE SMALL ONE ABOVE. NO AIR WAS NOTICED IN THE CURLIN TUBING. WHEN THE "RESTART" BUTTON WAS PUSHED THE INFUSION WOULD CONTINUE TO INFUSE (WITHOUT THE BEEP FOR A WHILE). THE PHYSICIAN WAS NOTIFIED AND PT TO BE MOVED TO THE CURLIN HOME PUMP ONCE DISCHARGE WAS CONFIRMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12139690 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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