Z-2319-2013Class II

DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container...

Name: Z-2319-2013 DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container...
Creator: DeVilbiss Healthcare LLC
Published: 2013-03-07
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2013-03-07 / Terminated

FDA source

DeVilbiss Healthcare LLC began a recall of DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and... on 2013-03-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2319-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Posted: 2013-10-01
Terminated: 2014-11-06
Recalling firm: Sunrise Medical, Inc.
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.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
FDA root cause: Use error
Action: DeVilbiss Healthcare sent End users a field corrective action letter dated March 7, 2013, to all affected customers to reinforce the proper cleaning method. This letter is to inform you that we have come across cases where end users had exposed the bacterial filter cartridge in the disposable suction container to fluid, thereby occluding the filter and rendering it unusable Specifically what do you have to do when you receive a correction/recall notice? " The US FDA states in its correction/recall regulations that: "Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees." "Enclosed you will find two Urgent Medical Device Correction letters addressed to DeVilbiss Dealer/Provider" and "DeVilbiss User" that we ask you read carefully. "It is important that you follow the actions outlined in these letters to ensure we can effectively disseminate this information to end-users. "To reach your direct accounts we ask that you send a copy of the "DeVilbiss User" letter to each of these end-users. We sincerely appreciate all of your efforts to ensure the safety of your customers that depend on DeVilbiss products. We thank you in advance for your assistance and apologize for any inconvenience that you may experience as a result of this situation. Should you have any questions or concerns, please contact DeVilbiss Healthcare Customer Service at 1-800-338-1988.
Quantity in commerce: 112,849
Distribution: Worldwide Distribution - USA and the countries of Mexico and Canada.
Product codes and lots: Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2319-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2319-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

Product code JCX

K982304Class IIDevilbiss Suction UnitSunrise Medical Hhg, Inc. / cleared 1998-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)