FDA-Device2021-10-06Class II
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical Corporation
Hazard
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Sold states
Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
Affected count
28 units
Manufactured in
40 Continental Blvd, N/A, Merrimack, NH, United States
Products
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2021Don't want to check this manually?
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