Atrium Medical Recalls Advanta SST Bifurcated Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SST Bifurcated 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, and the hazard involves a packaging/labeling issue that complicates sterile field preparation without explicit reports of patient injury or death in the source text.
Plain-English summary
Atrium Medical Corporation is recalling Advanta SST Bifurcated 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 adhesion can make it difficult to remove the tray onto the sterile field during surgical preparation.
The affected products were manufactured between April 3, 2012, and May 14, 2013. They can be identified by their expiration dates, which range between April 2017 and May 2018. The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare providers should stop using these specific lots and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Advanta SST Bifurcated 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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