Events

Recall of StarClose SE Vascular Closure System (VCS), International Green Sheath

According to Republic of Lebanon Ministry of Public Health, this recall involved a device in Lebanon that was produced by Abbott Vascular Division of Abbott Australasia Pty Ltd.

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
  • Date
    2017-02-20
  • Event Country
    Lebanon
  • Event Source
    RLMPH
  • Event Source URL
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202017/20-2-2017/StarCloseSEVascularClosureSystem.pdf
  • Notes / Alerts
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Extra notes in the data

Device

StarClose SE Vascular Closure System (VCS), International Green Sheath

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Manufacturers representative
    Medilife S.A.L
  • Source
    RLMPH