Z-2319-2013 Class II Terminated

Recalled by DeVilbiss Healthcare LLC — Somerset, PA

Recall Details

Product Type
Devices
Report Date
October 9, 2013
Initiation Date
March 7, 2013
Termination Date
November 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112,849

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - USA and the countries of Mexico and Canada.

Code Information

Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25