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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Atrium Medical Corporation
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2307-2013

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