Atrium Medical Recalls Advanta VXT Vascular Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
What this means for you
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/labeling issue that complicates the sterile setup process, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts, which are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. The recall affects grafts manufactured between April 3, 2012, and May 14, 2013, which can be identified by expiration dates between April 2017 and May 2018.
The reason for the recall is that the inner tray label may adhere to the wall of the outer tray. This adhesion makes it difficult to remove the tray onto the sterile field during use.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. The source text does not specify the number of units affected or report any illnesses or injuries associated with this issue.
The recalled product
- Product
- Advanta VXT 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
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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