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.
W L Gore & Associates, Inc.
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-2052-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief