Atrium Flixene IFG Vascular Grafts Recalled for Label Adhesion Issue
Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only problem (label adhesion) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or packaging defects.
Plain-English summary
Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts, which are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. The recall involves products manufactured between April 3, 2012, and May 14, 2013, with expiration dates between April 2017 and May 2018. These products were distributed nationwide in the United States and internationally to numerous countries.
The recall was initiated because the inner tray label may adhere to the wall of the outer tray. This adhesion can make it difficult to remove the tray onto the sterile field during surgical preparation. The issue is a packaging defect that may complicate the handling of the sterile device.
Healthcare facilities and distributors should check their inventory for Flixene IFG Vascular Grafts with the specified manufacturing and expiration dates. If these products are found, they should be removed from use and returned to Atrium Medical Corporation or the distributor as directed by the company.
The recalled product
- Product
- Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Grafts
- 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
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.
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