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 Codman Johnson & Johnson.

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 06 11 000
  • Event Initiated Date
    2011-06-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=495
  • 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
    Cracks have been identified in the sterile package tray in which these additional product are contained. the product in a cracked package may not be sterile and could result in an increased risk of infection should it be used.

Device

Codman Disposable Drill Kit Products
  • Model / Serial
    Products Codes: 80-1200, 80-1185: Ghajar Guide Ventriculostomy Kit 80-1190: Codman Metal Disposable ICP Kit 80-1196: Codman Plastic Disposable ICP Kit, Adult 80-1197: Codman Plastic Disposable ICP Kit, Pediatric 82-6607: Codman Cranial Hand Drill
  • Product Description
    Drills, Perforator
  • Manufacturer
    Codman Johnson & Johnson

Manufacturer

Codman Johnson & Johnson
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical, Riyadh (01) 4603292
  • Source
    SFDA