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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre Stent Guide

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 Class 2 Recall
LeMaitre Stent Guide
see related information
Date Posted April 04, 2013
Recall Status1 Terminated on December 03, 2014
Recall Number Z-1054-2013
Recall Event ID 64704
Premarket Notification
510(K) Number
Product Classification Assembly, Thigh/Knee/Shank/Ankle/Foot, External - Product Code KFX
Product LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Code Information LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
Recalling Firm/
LeMaitre Vascular, Inc.
63 2nd Ave
Burlington, Massachusetts 01803-4413
For Additional Information Contact Laurie Churchill
781-221-2266 Ext. 108
Manufacturer Reason
for Recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.
Quantity in Commerce 6970
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KFX and Original Applicant = VASCUTECH, INC.