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U.S. Department of Health and Human Services

Class 2 Device Recall VASCUTEK/TERUMO

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  Class 2 Device Recall VASCUTEK/TERUMO see related information
Date Initiated by Firm July 08, 2021
Create Date September 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-2542-2021
Recall Event ID 88278
510(K)Number K090987  K013022  K955230  K034010  
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
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
Code Information To be reported.
Recalling Firm/
Manufacturer		 Vascutek, Ltd.
Newmains Avenue
Inchinnan United Kingdom
Manufacturer Reason
for Recall		 The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
FDA Determined
Cause 2		 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 in Commerce 159 total vascular grafts and patches
Distribution Distribution was made to PR and Guam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSY and Original Applicant = SULZER CARBOMEDICS, INC.
510(K)s with Product Code = DSY and Original Applicant = VASCUTEK LTD.
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