Class II — DeVilbiss Healthcare LLC
| Recalling firm | Drive DeVilbiss Healthcare |
|---|---|
| Registered facility | DeVilbiss Healthcare LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. |
| Product | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order. |
| Quantity | 112,849 |
| Distribution | Worldwide Distribution - USA and the countries of Mexico and Canada. |
| Initiated | 2013-03-07 |
| Classified | 2013-09-30 |
| Terminated | 2014-11-06 |
| Recall number | Z-2319-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DeVilbiss Healthcare LLC (Z-2319-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66347/
Alerts for Drive DeVilbiss Healthcare
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.