Alaris, SmartSite 2466-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access Non-Vented Low Sorbing Tubing (PE Lined) 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 10885403221958), received between Nov 23, 2022 and Nov 23, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 ↗
- 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
- Material Deformation1
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.
MalfunctionNov 23, 2022Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD ALARIS¿ LVP SS BAG 20D LOW SORB THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON LOOKING AT THE TUBING, THE PART THAT FITS INTO THE PUMP WAS SMASHED COMPLETELY FLAT. HEALTH CARE PROVIDERS CALLED NURSE AND SHE HAD TO TAKE THE CHEMO DOWN TO PHARMACY AND REPLACE THE TUBING. ONCE THIS WAS DONE, THE CHEMOTHERAPY INFUSED WITHOUT ANY DIFFICULTY. IT WAS A FAULTY CHEMO TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15859254 ↗
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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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