Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Lifetech Scientific (Shenzhen) Co., Ltd..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 137 10 18 000
  • Event Initiated Date
    2018-10-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13392
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: BfArM
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Lifetech states that the size of the loader of the above systems may be too small, potentially causing difficulty for the matching delivery cable to pass through. lifetech also states that this problem can be noticed during pre-operative preparation, and that potential hazards include a delay in procedure and the need to replace the loader. lifetech further states that this problem occurs because the inner diameter of the loader did not reach its lower limit, which was caused by the manufacturing process problem of the supplier.

Device

Cera Vascular Plug Systems
  • Model / Serial
    LT-PLUG-04 1721010410180107211801070372, 1721010410180107211801070373, 1721010410180107211801070374, 1721010410180107211801070375, 1721010410180107211801070376, 172101041018010721801070377 180107 LT-PLUG-04 1721011810180134211801340251, 172101181018013421801340252, 1721011810180134211801340253, 1721011810180134211801340254, 1721011810180134211801340255, 1721011810180134211801340256, 1721011810180134211801340258, 1721011810180134211801340259, 1721011810180134211801340260 180134 LT-PLUG-06 1720122710171252211712521320, 1720122710171252211712521321, 1720122710171252211712521322, 1720122710171252211712521323, 1720122710171252211712521327, 1720122710171252211712521328, 1720122710171252211712521329, 1720122710171252211712521330 171252 LT-PLUG-06 1721010410180107211801070384, 1721010410180107211801070385, 1721010410180107211801070386, 1721010410180107211801070387, 1721010410180107211801070388, 1721010410180107211801070389 180107 LT-PLUG-06 1721012410180146211801460777, 1721012410180146211801460778, 1721012410180146211801460779 180146 LT-PLUG-06 1720122710171252211712521325, 1720122710171252211712521324 171252 LT-PLUG-06 1721012410180146211801460780, 172101241018014621801460781 180146
  • Product Description
    Vascular Closure Devices
  • Manufacturer
    Lifetech Scientific (Shenzhen) Co., Ltd.

Manufacturer

Lifetech Scientific (Shenzhen) Co., Ltd.