Device 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.
Z-2319-2013
Product summary
- Event
- Event 66347
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,849
- Official record key
device-enforcement:Z-2319-2013
Official wording
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.
Code information: Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25
Distribution pattern: Worldwide Distribution - USA and the countries of Mexico and Canada.
Derived failure modes
-
Unknown
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.