Recall Z-2542-2021— Vascutek, Ltd.
Class II · Terminated
Class II FDA medical device recall by Vascutek, Ltd., initiated 2021-07-08, terminated 2024-08-19. It names 4 FDA 510(k) clearances: K090987, K034010, K013022 and 1 more. 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. Reason: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees..
- Recalling firm
- Vascutek, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-08
- Terminated
- 2024-08-19
- Firm location
- Inchinnan, N/A, United Kingdom
510(k) clearances named in this recall
4 on FDA's record- K090987 — VASCUTEK BRANCHED GELWEAVE
- K034010 — GELSOFT PLUS ERS
- K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
- K955230 — VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Data sourced from openFDA. This site is unofficial and independent of the FDA.