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 Maquet Cardiopulmonary AG.

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 095 08 14 000
  • Event Initiated Date
    2014-08-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6326
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    An internal finding identified the presence of pinholes/cuts in some of the tyvek pouches of the vacuum tubing sets included as an accessory to these products. there is a potential for the pouch’s integrity to be compromised.

Device

ACROBAT V and ACROBAT SUV Systems and the XPOSE 3 and XPOSE 4 Devices
  • Model / Serial
    Product Name : ACROBAT V Vacuum Off-Pump System Product Code/REF Number : OM-9100S Product Name : ACROBAT SUV Vacuum Off-Pump System Product Code/REF Number : OM-9000S Product Name : AXIUS XPOSE 3 Access Device Product Code/REF Number : XP-3000 Product Name : XPOSE 4 Access Device Product Code/REF Number : XP-4000
  • Product Description
    Suture, heart surgery
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 12119948
  • Source
    SFDA