FDA-Device2021-10-06Class II
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Vascutek, Ltd.
Hazard
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Sold states
Distribution was made to PR and Guam.
Affected count
159 total vascular grafts and patches
Manufactured in
Newmains Avenue, N/A, Inchinnan, N/A, United Kingdom
Products
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2021Don't want to check this manually?
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