Devices

Device Recall Flixene Trumpet Grafts

Model / Serial
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
Product Description
Flixene Trumpet Grafts >or= 6mm || Flixene GW and GWT Grafts >or= 6mm || Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Manufacturer
Atrium Medical Corporation
1 Event
- Recall of Device Recall Flixene Trumpet Grafts

Manufacturer

Atrium Medical Corporation

Manufacturer Address
Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA

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