medical Class II Updated 2021-10-06

Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Carotid Patch and Gelso

Recalled Product

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t


Hazard / Issue

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Issued by

FDA

Distribution: Distribution was made to PR and Guam.
Lot/Code Info: To be reported.
View official government recall

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