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U.S. Department of Health and Human Services

Class 3 Device Recall Tumescent Catheter Inversion System

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  Class 3 Device Recall Tumescent Catheter Inversion System see related information
Date Initiated by Firm February 24, 2015
Date Posted March 18, 2015
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-1294-2015
Recall Event ID 70698
510(K)Number K041453  
Product Classification Stripper, vein, external - Product Code DWQ
Product LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein.
Catalog Number: 7210023, lot #61049252
Code Information Lot Number: 61049252 Exp. Date: 2016-06
Recalling Firm/
LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Laurie Churchill
781-425-1670 Ext. 108
Manufacturer Reason
for Recall
Mislabeled with an incorrect expiration date
FDA Determined
Cause 2
Employee error
Action LeMaitre Vascular issued a Field Safety Notice/Dear Doctor dated 2/24/15 to customers The letter provides information on the recalled product and instructions on how the customer can inspect for the defective devices and return the affected products for replacement/credit. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Questions, contact 781-221-2266 ext. 183
Quantity in Commerce 54 units
Distribution CA, CO, KS, MN, UT, WA, WI
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWQ and Original Applicant = SMITH & NEPHEW, INC.