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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00737-1
Product Name/Description PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018

Multiple catalogue and lot numbers affected

ARTG Numbers: 154085, 155155, 155159, 155171, 154087, 155157, 155158, 155161, 155168, 155957, 176909, 155225, 182788
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/07/2013
Responsible Entity Atrium Australia - Pacific Rim Pty Limited
Reason/Issue Atrium Medical has become aware that the label on the tab of the inner Tyvek cover can adhere, to the inside wall of the outer tray. This may make it more difficult to employ the user's current technique which is to first pass the inner tray from the outer tray and then onto the sterile field. In some cases, because of the sticking of the inner tray to the outer tray, it has been reported that the inner tray must be lifted from the outer tray.
Recall Action Recall for Product Correction
Recall Action Instructions Atrium medical are advising users of work around instructions to follow to prevent the issue from occurring.
Contact Information 1800 605 824 - Atrium Australia