Recall Z-2543-2021 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Vascutek, Ltd.
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
| Date | Jul 8, 2021 |
| Status | Terminated |
| Reason | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 159 total vascular grafts and patches |
| Distribution | Distribution was made to PR and Guam. |
| FDA record | Open on fda.gov |