Events

Recall of AnastoClip AC Closure System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2017-RN-00145-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00145-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, lemaitre vascular has identified that the box labels for certain lots of catalogue numbers 4012-02 and 4012-03 have an incorrect dimension listed. the box label for each size device illustrates a clip gap that is smaller by 0.3mm – 0.5mm than the actual clip of each size product. the ifu and tyvek labels for the product have the correct size of the clip gap noted for each size. there have been no complaints about this issue.
  • Action
    Emergo is advising customers that all affected product should be returned for replacement. This action has been closed-out on 06/07/2017.

Device

AnastoClip AC Closure System
  • Model / Serial
    AnastoClip AC Closure SystemCatalogue Number: 4012-02 Lot Numbers: EAV1023 (Expiry Dec. 2020), EAV1032 (Expiry Sept. 2021)Catalogue Number: 4012-03Lot Number: EAV1016 (Expiry 28 Oct. 2020)ARTG Number: 120976
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia