Atrium Flixene Grafts Recalled Due to Difficult Tray Removal
Atrium Medical Corporation is recalling Flixene Trumpet 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 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. The hazard involves a packaging issue that makes the device difficult to remove from its tray, which is a moderate risk but does not involve a direct structural defect or reported serious injury.
Plain-English summary
Atrium Medical Corporation is recalling Flixene Trumpet Grafts and Flixene GW and GWT Grafts that are 6mm or larger. These medical devices are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
The recall was initiated because the inner tray label may adhere to the wall of the outer tray. This issue makes it difficult to remove the tray onto the sterile field. The affected products were manufactured between April 3, 2012, and May 14, 2013, and can be identified by expiration dates between April 2017 and May 2018.
The products were distributed nationwide in the United States and internationally to numerous countries. Healthcare providers and facilities should stop using these specific lots and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT 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
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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