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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-2543-2021
Recall Event ID 88278
510(K)Number K972201  K963611  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches.

FSN says Tapered Carotid Patch 920875t
Code Information To be reported.
Recalling Firm/
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 = DXZ and Original Applicant = SULZER CARBOMEDICS, INC.
510(K)s with Product Code = DXZ and Original Applicant = VASCUTEK LTD.