Atrium ADVANTA VXT Vascular Graft recall: Labeling Error
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental…
Why was Atrium ADVANTA VXT Vascular Graft recalled?
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 458755 Serial numbers 458755001 458755007 458755013 458755019 458755025 458755002 458755008 458755014 458755020 458755026 458755003 458755009 458755015 458755021 458755027 458755004 458755010 458755016 458755022 458755028 458755005 458755011 458755017 458755023 458755029 458755006 458755012 458755018 458755024 458755030
- Product
- Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 28 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)