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U.S. Department of Health and Human Services

Class 3 Device Recall LeMaitre VascuTape Radiopaque Tape

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  Class 3 Device Recall LeMaitre VascuTape Radiopaque Tape see related information
Date Initiated by Firm October 22, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on September 15, 2011
Recall Number Z-0436-2011
Recall Event ID 57028
510(K)Number K932184  
Product Classification Measuring Tape, Rulers and Calipers - Product Code FTY
Product LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips
Catalog Number: 1108-20

Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference.
Code Information Lot Number Exp Date GTFI024 2015-06; GTFI027 2015-07
Recalling Firm/
Manufacturer		 Lemaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Aaron Grossman
781-221-2266 Ext. 158
Manufacturer Reason
for Recall		 Box label (Top Part). Lot and Expiration Date information were switched.
FDA Determined
Cause 2		 Labeling Change Control
Action Lemaitre Vascular notified customers by an Urgent: VascuTape Radiopaque Tape Device Field Safety Notice letter on 10/22/10 via USPS with delivery confirmation. The Notice advised users of the incorrect lot and lot number on the outer box and also provided an image of the box and label for ease in identifying the product in their inventory. The letter states that the use and functionality of the device are not affected by the problem; however, if customers feel uncomfortable continuing to use the affected device, they can contact Customer Service for replacement. The firm recommended discarding the outer box of the affected product. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. Accounts can contact customer service at 800-628-9470.
Quantity in Commerce 580 units
Distribution Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
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 = FTY and Original Applicant = VASCUTECH, INC.
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