FDA recall Z-2543-2021

Vascutek, Ltd. · Class II · device

Product

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

Reason for recall

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

Distribution

Distribution was made to PR and Guam.

Key facts

Status
Terminated
Initiation date
2021-07-08
Report date
2021-10-06
Termination date
2024-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Inchinnan, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2021