Date Initiated by Firm |
March 18, 2013 |
Date Posted |
April 04, 2013 |
Recall Status1 |
Terminated 3 on December 03, 2014 |
Recall Number |
Z-1055-2013 |
Recall Event ID |
64704 |
510(K)Number |
K932184
|
Product Classification |
Assembly, thigh/knee/shank/ankle/foot, external - Product Code KFX
|
Product |
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).
Intended to be placed on the skin to assist during imaging procedures. |
Code Information |
SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09 |
Recalling Firm/ Manufacturer |
LeMaitre Vascular, Inc. 63 2nd Ave Burlington MA 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 |
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 |
13560 |
Distribution |
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia. |
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.
|
510(K) Database |
510(K)s with Product Code = KFX and Original Applicant = VASCUTECH, INC.
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