Alaris 10014081Recalls & reported problems
BD Switzerland Sàrl · Secondary Blood Set, 200 Micron Filter, Nonvented 81 cm (32 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403233845), received between Jun 21, 2022 and Jul 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Defective Component2
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.
MalfunctionJul 29, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE BD SECONDARY BLOOD SETS EXPERIENCED DEFECTIVE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE LEARNED OF ANOTHER BLOOD SET DEFECT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136203 ↗MalfunctionJun 21, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE BD SECONDARY BLOOD SETS - SET, BLOOD, SECONDARY, W/200 MIC FILT EXPERIENCED ASSEMBLED INCORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE NURSE WAS ABOUT TO HANG A BLOOD PRODUCT WITH SECONDARY BLOOD TUBING. SHE REMOVED THE BLOOD TUBING FROM THE PACKAGE AND NOTICED THE FILTER WAS MANUFACTURED "UPSIDE DOWN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14756144 ↗
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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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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