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U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss Healthcare

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 Class 2 Recall
DeVilbiss Healthcare
see related information
Date Posted October 01, 2013
Recall Status1 Terminated on November 06, 2014
Recall Number Z-2319-2013
Recall Event ID 66347
Premarket Notification
510(K) Number
K872094 
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, Pennsylvania 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 2
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JCX and Original Applicant = THE DEVILBISS CO.
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