FDAFDA · Food and drugs·Recall number Z-2319-2013
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.
Published October 9, 2013 · Recall initiated: March 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeVilbiss Healthcare LLC
- Distributor
- Worldwide Distribution - USA and the countries of Mexico and Canada.
- Lot
- Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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