FDA-Device2020-05-27Class II
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Hazard
The incorrect label was placed on both the primary and secondary package.
Sold states
International the country of Japan.
Affected count
15 stents
Manufactured in
1500 N 4th St, N/A, Flagstaff, AZ, United States
Products
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2020More W L Gore & Associates, Inc. recalls
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