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 Bard Pcripheral Vascular (BPV).

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 043 12 17 000
  • Event Initiated Date
    2017-12-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11876
  • 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
    Bard peripheral vascular inc,. was notified that the atlas® gold and vida balloons produced from september 2016 had an increase in the upper limit of the double wall thickness. the double wall thickness acceptance range of the balloon was changed from 0.0042 – 0.0049” to 0.0042 to 0.00565” by futurematrix interventional (fmi) who produce the atlas gold and vida products for bard.

Device

Balloon wall thickness of ATLAS® GOLD PTA Dilatation Catheter
  • Model / Serial
    Multiple affected codes are provided in the attached FSN.
  • Product Description
    Dilatation Catheter
  • Manufacturer
    Bard Pcripheral Vascular (BPV)

Manufacturer

Bard Pcripheral Vascular (BPV)