Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion Issue
Atrium Medical Corporation is recalling Advanta SST 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 FDA Class II, but the specific defect is a packaging-only problem (label adhesion) that does not directly cause adverse health consequences or injury, fitting the criteria for a Low severity score.
Plain-English summary
Atrium Medical Corporation is recalling Advanta SST Grafts, which are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. The recall is due to a packaging issue where 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.
The affected products were manufactured between April 3, 2012, and May 14, 2013. These specific units can be identified by their expiration dates, which fall between April 2017 and May 2018. The products were distributed worldwide, including nationwide in the United States and to numerous international locations.
Healthcare providers and facilities should check their inventory for Advanta SST Grafts with expiration dates between April 2017 and May 2018. If these products are found, they should be removed from use and returned to Atrium Medical Corporation or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Advanta SST Grafts <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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