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 Smith & Nephew.

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 020 03 17 000
  • Event Initiated Date
    2017-03-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10753
  • 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
    Smith & nephew, inc. has initiated a field correction for the dyonics battery power hand pieces due to an error in the operator manual. the operator manual contains incorrect dry time for pre-vacuum steam sterilization and gravity displacement steam sterilization cycles. the operator manual incorrectly states the minimum dry time as “8 minutes” for all devices; however, the correct dry times should be longer and are provided in the attached fsn.

Device

DYONICS Battery Power Hand Pieces
  • Model / Serial
    Product No.: 72204114, 72204091, 72204092, 72204093 For more details see attached FSN
  • Product Description
    Electro mechanical medical device
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew