Recall Z-2319-2013— DeVilbiss Healthcare LLC

Name: FDA recall Z-2319-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Class II · Terminated

Class II FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2013-03-07, terminated 2014-11-06. It names one FDA 510(k) clearance: K982304. 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.. 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..

Recalling firm: DeVilbiss Healthcare LLC
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Terminated: 2014-11-06
Firm location: Somerset, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K982304 — DEVILBISS SUCTION UNITSunrise Medical Hhg, Inc.·cleared 1998-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.