Bemis HIFLOW 494410Recalls & reported problems
Bemis Manufacturing Company · 2000cc/ml Suction canister with aerostat filter, float valve shutoff, green lid · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10073088150049), received between Jan 31, 2017 and Jan 31, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Aspiration Issue” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Aspiration Issue1
Patient problems
- Aspiration/Inhalation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2017Aspiration Issue; Aspiration Issue
PATIENT NEEDED ASPIRATION AND SUCTION DID NOT WORK.
Patient problems: Aspiration/Inhalation
MAUDE report 6289883 ↗
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- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.