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

FDA device recall Z-2319-2013 · posted 2013-10-01 · Terminated

Recall details

Recalling firm

DeVilbiss Healthcare LLC

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.

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

JCX

Quantity affected

112,849

Distribution

Worldwide Distribution - USA and the countries of Mexico and Canada.

Date initiated

2013-03-07

Date posted

2013-10-01

Date terminated

2014-11-06

Location

Somerset, PA

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