Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Reported: October 9, 2013 Initiated: July 12, 2013 #Z-2307-2013
Product Description
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Reason for Recall
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Details
- Recalling Firm
- Atrium Medical Corporation
- 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
- Location
- Hudson, NH
Frequently Asked Questions
What product was recalled? ▼
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.. Recalled by Atrium Medical Corporation.
Why was this product recalled? ▼
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2013. Severity: Moderate. Recall number: Z-2307-2013.
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