Recall Z-2543-2021
Vascutek, Ltd. · initiated July 8, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Codes / lots: To be reported.
Reason for recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2543-2021
- Initiated
- July 8, 2021
- Terminated
- August 19, 2024
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- 159 total vascular grafts and patches
- Distribution
- Distribution was made to PR and Guam.
- Recalling firm
- Vascutek, Ltd., Inchinnan
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2542-2021 Class II | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem…The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. | 07/08/2021Terminated |