Z-2307-2013Class II

Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass...

Name: Z-2307-2013 Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass...
Creator: Atrium Medical Corporation
Published: 2013-07-12
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2013-07-12 / Terminated / root cause: packaging

FDA source

Atrium Medical Corporation began a recall of Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access on 2013-07-12. FDA classified it as Class II and gives the reason as "Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2307-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-12
Posted: 2013-09-30
Terminated: 2014-07-15
Recalling firm: Atrium Medical Corporation
Product: Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at [email protected]
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 codes and lots: Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2307-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2304-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2305-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2306-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2307-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2308-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2309-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2310-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2311-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2312-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2313-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2314-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2315-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2316-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2317-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

Product code DSY

K122138Class IIAtrium Flixene Ifg Vascular GraftAtrium Medical Corp. / cleared 2012-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)