Date Initiated by Firm | July 08, 2021 |
Create Date | September 24, 2021 |
Recall Status1 |
Terminated 3 on August 19, 2024 |
Recall Number | Z-2543-2021 |
Recall Event ID |
88278 |
510(K)Number | K963611 K972201 |
Product Classification |
Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DXZ 510(K)s with Product Code = DXZ
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