LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number: 1102-00 Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference.
FDA Recall Z-0434-2011 · Posted 2010-11-22
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Recalling FirmLemaitre Vascular, Inc.
Recall StatusTerminated
Product CodeFTY
Date Initiated2010-10-22
Date Terminated2011-09-15
Product Quantity200 units
Reason for Recall
Box label (Top Part). Lot and Expiration Date information were switched.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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