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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/TERUMOsee related information
Date Initiated by FirmJuly 08, 2021
Create DateSeptember 24, 2021
Recall Status1 Terminated 3 on August 19, 2024
Recall NumberZ-2543-2021
Recall Event ID 88278
510(K)NumberK963611 K972201 
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
ProductThe 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 2
Under Investigation by firm
ActionThe 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 Commerce159 total vascular grafts and patches
DistributionDistribution was made to PR and Guam.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXZ
510(K)s with Product Code = DXZ
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