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 Advanced Sterilization Products.

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 016 05 12 000
  • Event Initiated Date
    2012-05-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1797
  • 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
    This letter applies to all lots of glosair™ 400 cartridges (cartridges) shipped within the past year that indicate a storage temperature of 5º - 40ºc. asp has recently determined that the cartridges, if stored at the upper extreme of the permitted labeled temperature requirements, may not meet product specifications for end of shelf life. while you can be assured that this presents no health risk, in keeping with our commitment to provide customers with quality products, asp has voluntarily decided to recall the product, and will be correcting future product to reflect the appropriate storage conditions and shelf life.

Device

Cleaning, GLOSAIR™ 400 Cartridges

Manufacturer

Advanced Sterilization Products
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
  • Source
    SFDA