The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2307-2013·Announced 2013-10-09

Atrium Flixene IFG Recall Due to Label Adhesion Issue

Atrium Medical Corporation is recalling Flixene IFG with Assisted Delivery because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific defect involves a packaging issue (label adhesion) that makes removal difficult rather than causing direct injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Atrium Medical Corporation is recalling Flixene IFG with Assisted Delivery, a medical device intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. The recall is due to a defect where the inner tray label may adhere to the wall of the outer tray, which makes it difficult to remove the tray onto the sterile field.

The affected products were manufactured between April 3, 2012, and May 14, 2013. These units can be identified by their expiration dates, which range between April 2017 and May 2018. The products were distributed nationwide in the United States and internationally to numerous countries, including Canada, Mexico, Australia, and various nations in Europe, Asia, and South America.

Healthcare providers and facilities should stop using the affected Flixene IFG with Assisted Delivery products and contact Atrium Medical Corporation for instructions on how to return or dispose of the units. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular Graft
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product manufactured between April 3
  • 2012 and May 14
  • 2013 and can be identified by their expiration date
  • between April 2017 and May 2018.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Atrium Medical Corporation

See all →

Same hazard · packaging defect

See all →

Similar recalls