Z-2543-2021 Class II Terminated
FDA device recall Z-2543-2021 was initiated by Vascutek, Ltd. on July 8, 2021 and is designated Class II. Reason for recall: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. The recall status is terminated (terminated August 19, 2024). Affected quantity: 159 total vascular grafts and patches.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- July 8, 2021
- Termination Date
- August 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 total vascular grafts and patches
Product Description
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 Pattern
Distribution was made to PR and Guam.
Code Information
To be reported.