Alaris 10387509Recalls & reported problems
BD Switzerland Sàrl · Gravity Blood Set, 200 Micron Filter Nonvented 267 cm (105 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403234217), received between Aug 18, 2023 and Dec 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Misassembled” (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.
Reports received per month
Most reported problems
Device problems
- Misassembled2
- Component Misassembled1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Fluid Discharge1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Component Misassembled; Component Misassembled
MATERIAL# 10387509, BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT HELLO TODAY WE RECEIVED AN ADDITIONAL REPORT OF AN INVERTED FILTER ON THE 200 MICRON FILTER BLOOD GRAVITY SET REF#(B)(4). IT IS IMPERATIVE THAT WE DO NOT RETAIN DEFECTIVE SETS IN OUR ENVIRONMENT AS THIS IS HINDERING TIMELY PATIENT CARE AND CAUSING UNNECESSARY WASTE OF BLOOD PRODUCTS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HELLO TODAY WE RECEIVED AN ADDITIONAL REPORT OF AN INVERTED FILTER ON THE 200 MICRON FILTER BLOOD GRAVITY SET REF#(B)(4). IT IS IMPERATIVE THAT WE DO NOT RETAIN DEFECTIVE SETS IN OUR ENVIRONMENT AS THIS IS HINDERING TIMELY PATIENT CARE AND CAUSING UNNECESSARY WASTE OF BLOOD PRODUCTS.
Patient problems: Fluid Discharge
MAUDE report 20893133 ↗MalfunctionOct 23, 2024Component Missing; Component Missing
IT WAS REPORTED THAT BD ALARIS GRAVITY BLOOD SET WAS MISSING A COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT PLATELET TUBING MISSING THE ROLLER CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517846 ↗MalfunctionJun 26, 2024Misassembled; Misassembled
IT WAS REPORTED THAT BD ALARIS GRAVITY BLOOD SET WAS DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: "I GOT A COMPLAINT FROM NURSING ABOUT BLOOD TUBING MANUF # 10387509 (LOT # 24019346) HAVING AN ISSUE. THE PROBLEM IS THE FILTER CHAMBER PART OF THE TUBING WAS ACTUALLY MANUFACTURED INVERTED. I HAVE THE AFFECTED PRODUCT BUT IT DOES HAVE BLOOD IN IT. THIS EVENT OCCURRED ON 5/30/2024. THERE WAS NO EXPOSURE. I HAVE ATTACHED A PHOTO OF THE ITEM. IF YOU NEED ANYTHING ELSE LET ME KNOW. PLEASE SEND RETURN LABEL AND CONTAINER FOR CONTAMINATED ITEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19618904 ↗MalfunctionAug 18, 2023Misassembled; Misassembled
IT WAS REPORTED THAT BD GRAV BLD SET 200MF 20 DP FILTER WAS INVERTED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER WITH THE VERBATIM: ¿BD GRAVITY BLOOD 200 MICRON FILTER NONVENTED¿ TUBING IN WHICH THE FILTER IS INVERTED. - WAS THE EVENT DISCOVERED BEFORE USE/DURING USE? BEFORE USE - WAS THERE ANY PATIENT INVOLVEMENT? NO - IF YES, WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? - WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? MINIMAL DELAY, NURSE JUST GRABBED ANOTHER SET. - WHAT TYPE OF PROCEDURE IS BEING PERFORMED? SET HAD NOT BEEN HOOKED UP TO PRBC YET SO NO PROCEDURE. - WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NOTHING, SET HAD NOT BEEN SPIKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573710 ↗
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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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