Recall Z-2542-2021 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Vascutek, Ltd.
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Va
| 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 |