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Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Pat
Recalled October 6, 2021 · FDA recall Z-2543-2021 · Vascutek
Hazard
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. · FDA Class II
Units
159 total vascular grafts and patches
Sold at
Distribution was made to PR and Guam.
Description
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Manufacturer(s)
Vascutek, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →