Alaris 10016242Recalls & reported problems
BD Switzerland Sàrl · Secondary Blood Set, 200 Micron Filter Nonvented Hanger 81 cm (32 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613203017398), received between Jun 23, 2025 and Jul 10, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Misassembled” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Misassembled6
- Separation Problem3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788722 ↗MalfunctionJul 10, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788719 ↗MalfunctionJul 10, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788717 ↗MalfunctionJun 23, 2025Misassembled; Device Contamination with Chemical or Other Material; Misassembled; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT MULTIPLE REPORTS OF FILTERS BEING UPSIDE DOWN AND PATIENT CARE IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309646 ↗MalfunctionJun 23, 2025Misassembled; Misassembled
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT ONGOING ISSUE WITH OUR SECONDARY BLOOD TUBING WHERE THE TUBING IS DEFECTIVE BECAUSE THE FILTER IS UPSIDE DOWN AND IT CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309324 ↗MalfunctionJun 23, 2025Misassembled; Misassembled
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT ONGOING ISSUE WITH OUR SECONDARY BLOOD TUBING WHERE THE TUBING IS DEFECTIVE BECAUSE THE FILTER IS UPSIDE DOWN AND IT CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309262 ↗MalfunctionJun 23, 2025Misassembled; Misassembled
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309260 ↗MalfunctionJun 23, 2025Misassembled; Misassembled
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT ONGOING ISSUE WITH OUR SECONDARY BLOOD TUBING WHERE THE TUBING IS DEFECTIVE BECAUSE THE FILTER IS UPSIDE DOWN AND IT CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309259 ↗MalfunctionJun 23, 2025Misassembled; Misassembled
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT ONGOING ISSUE WITH OUR SECONDARY BLOOD TUBING WHERE THE TUBING IS DEFECTIVE BECAUSE THE FILTER IS UPSIDE DOWN AND IT CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309224 ↗
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
- 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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