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 Atrium Medical Corporation.

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 039 10 18 000
  • Event Initiated Date
    2018-10-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13290
  • 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
    This letter is intended to provide clarification about the current packaging configuration of the atrium ocean, oasis, express and express mini chest drainage products. atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is folded over and secured with the package label. this packaging system is the same configuration used on atrium chest drainage products for the past 30 years. this field notification is to provide clarification as to which part of the packaged drain is sterile. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile; the outer dust cover is not sterile. the two sterilization wraps are what provide the sterile barrier for the product.

Device

ATRIUM OCEAN, OASIS, EXPRESS and EXPRESS MINI CHEST DRAINS
  • Model / Serial
    All Lot Numbers With Expiration Date Prior To October 2019
  • Product Description
    Water Seal Chest Drain
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Manufacturers representative
    Gulf Medical Co.
  • Source
    SFDA