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DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction… recallZ-2319-2013 · DeVilbiss Healthcare LLC · initiated Mar 7, 2013

Class II Terminated All recalls posted in October 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DeVilbiss Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Use error

What the company is doing

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.

Recall details

Recall number
Z-2319-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 7, 2013
Posted by the FDA
Oct 1, 2013
Recalling firm
DeVilbiss Healthcare LLC
Quantity
112,849
Product code
JCX
FDA submissions
K982304
Distribution
Worldwide Distribution - USA and the countries of Mexico and Canada.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

8 devices cleared under K982304 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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