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 Baxter Healthcare.

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 183 07 13 000
  • Event Initiated Date
    2013-07-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4061
  • 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
    Baxter would like to notify you of a recall of the above mentioned product due to the discovery of pinholes defects in the clear bottom film of the packaging. a potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection.

Device

Various Irrigation Sets Used with UROMATIC and ARTHROMATIC Plastic Containers
  • Model / Serial
    Product codes (2C4013; 2C4030; 2C4031). Product code 2C4030 was distributed in Saudi Arabia between 2001 and 2006. Lot numbers: ( U580647R, UR123497, UR123612, UR127241, UR187971, UR232744, UR254078, UR287730 & UR312652 )
  • Product Description
    Irrigators, Surgical Site
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA