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 Teleflex Medical.

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 062 11 16 000
  • Event Initiated Date
    2016-11-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10212
  • 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
    Teleflex is recalling this product due to a potential incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is a potential for infection to occur.

Device

ARROW OnControl Biopsy System Tray
  • Model / Serial
    Product Codes: 9403‐EU‐006, 9403‐VC‐006, 9408‐EU‐006, 9408‐VC‐006, 9411‐EU‐006, 9411‐VC‐006, 9451‐VC‐006, 9458‐VC‐006, 9461‐VC‐001, 9461‐VC‐006, 9462‐EU‐001, 9462‐VC‐001, 9462‐VC‐006, 9463‐EU‐001, 9463‐VC‐001, 9463‐VC‐006, 9464‐EU‐001, 9464‐VC‐001, 9464‐VC‐006, 9465‐VC‐001, 9465‐VC‐006, 9466‐EU‐001, 9466‐VC‐001, 9466‐VC‐006, 9470‐VC‐006, 9471‐VC‐006, 9472‐VC‐006 Multiple lot numbers of the affected device are provided in the attached FSN.
  • Product Description
    Bone Marrow Biopsy System
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Manufacturers representative
    Ebrahim M. Al-Mana & Bros. Co. Ltd.
  • Source
    SFDA