Class 2 Device Recall VASCUTEK/TERUMO

• Date Initiated by Firm: July 08, 2021
• Create Date: September 24, 2021
• Recall Status: Open, 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/ 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: 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.