FDA Recall
Terminated
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Recall: Z-2543-2021
·
Initiated July 8, 2021
Recall
- Recall Number
- Z-2543-2021
- Event Number
- 88278
- Firm
- Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom
- FEI Number
- 3002808437
- Product Code
- DXZ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 8, 2021
- Terminated
- August 19, 2024
Description
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Reason
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Action
The recalling firm sent emails on 7/8/2021 to the two distributors that contained the Field Safety Notice and the correct IFU to be supplied with products distributed to the United States.
Distribution
Distribution was made to PR and Guam.
Quantity
159 total vascular grafts and patches