Device product
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 Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile
Z-2542-2021
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-2542-2021
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.