Z-2542-2021 Class II Terminated
FDA device recall Z-2542-2021 was initiated by Vascutek, Ltd. on July 8, 2021 and is designated Class II. Reason for recall: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. The recall status is terminated (terminated August 19, 2024). Affected quantity: 159 total vascular grafts and patches.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- July 8, 2021
- Termination Date
- August 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 total vascular grafts and patches
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.
Distribution Pattern
Distribution was made to PR and Guam.
Code Information
To be reported.