Class 2 Device Recall DeVilbiss Healthcare

• Date Initiated by Firm: March 07, 2013
• Date Posted: October 01, 2013
• Recall Status: Terminated on November 06, 2014
• Recall Number: Z-2319-2013
• Recall Event ID: 66347
• 510(K)Number: K982304
• Product Classification: Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
• 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.
• Code Information: Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25
• Recalling Firm/ Manufacturer: DeVilbiss Healthcare LLC; 100 Devilbiss Dr; Somerset PA 15501-2125
• For Additional Information Contact: DeVilbiss Healthcare Customer Service; 800-338-1988
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JCX and Original Applicant = SUNRISE MEDICAL HHG, INC.