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W L Gore & Associates, Inc. recalls Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair o
Recalled May 27, 2020 · FDA recall Z-2052-2020 · W L Gore & Associates
Hazard
The incorrect label was placed on both the primary and secondary package. · FDA Class II
Units
15 stents
Sold at
International the country of Japan.
Description
The incorrect label was placed on both the primary and secondary package.
Product
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Manufacturer(s)
W L Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →