Events

Recall of LeMaitre VascuTape Radiopaque Tape

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lemaitre Vascular, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57028
  • Event Risk Class
    Class 3
  • Event Number
    Z-0436-2011
  • Event Initiated Date
    2010-10-22
  • Event Date Posted
    2010-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95211
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Measuring Tape, Rulers and Calipers - Product Code FTY
  • Reason
    Box label (top part). lot and expiration date information were switched.
  • 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.

Device

LeMaitre VascuTape Radiopaque Tape
  • Model / Serial
    Lot Number Exp Date GTFI024 2015-06; GTFI027 2015-07
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
  • Product Description
    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.
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • Manufacturer Address
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA