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 Kensey Nash Corp.

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 056 04 12 000
  • Event Initiated Date
    2012-04-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1687
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The device, collaguide collagen dental membrane, is sterilized by exposure to ethylene oxide. it was discovered that the devices subject to this recall were not placed in the load configuration as validated during the sterilization validation. it is unknown if the devices received the proper level of eto exposure. this defect may affect the safety of the device as the lethality of the process applied is uncertain.

Device

Dental Membrane, CollaGuide Collagen
  • Model / Serial
    Lot/batch no.: 94764, 95910, 98343, 94765, 95911, 97040, 94766 and 95912
  • Product Description
    Dental Membrane
  • Manufacturer
    Kensey Nash Corp

Manufacturer

Kensey Nash Corp