Device product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Z-2543-2021
Product summary
- Firm
- Vascutek, Ltd.
- Event
- Event 88278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 159 total vascular grafts and patches
- Official record key
device-enforcement:Z-2543-2021
Official wording
Reason: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Code information: To be reported.
Distribution pattern: Distribution was made to PR and Guam.
Derived failure modes
-
Unknown
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.