medical Class II Updated 2020-05-27

W L Gore & Associates, Inc. recalls Conformable Thoracic Stent Graft, Rx only, Sterile EO - Prod

Recalled 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.


Hazard / Issue

The incorrect label was placed on both the primary and secondary package.

Issued by

FDA

Distribution: International the country of Japan.
Lot/Code Info: Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084
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