Events

Recall of LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702

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
    56908
  • Event Risk Class
    Class 3
  • Event Number
    Z-0164-2011
  • Event Initiated Date
    2010-09-22
  • Event Date Posted
    2010-10-28
  • 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=94900
  • 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
    Applier, hemostatic clip - Product Code HBT
  • Reason
    Mislabeled size on external packaging: the contents section listed on the tyvek lid labels of the medium and large sizes incorrectly identified the size of the clip as xl, while the device inside was either a medium or large size.
  • Action
    LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.

Device

LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702
  • Model / Serial
    Lot Number Expiration Date  AGC1015 2012-10 AGC1016 2012-10 AGC1017 2012-10 AGC1018 2012-11 AGC1019 2012-11 AGC1022 2012-11 AGC1023 2012-11 AGC1024 2012-12 AGC1025 2013-01 AGC1027 2013-01 AGC1028 2013-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
  • Product Description
    LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size || Models: || 4007-02 Medium size 3 Pack || 4008-02 Medium size 10 Pack || 4007-06 Medium size 1 Pack || Manufactured by LeMatire Vascular Inc, Burlington, MA 01803
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

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