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 Ethicon Inc..

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 036 12 18 000
  • Event Initiated Date
    2018-12-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13592
  • 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
    Ethicon has confirmed that some devices contained in these lots may have been assembled without a washer.

Device

PROXIMATE Hemorrhoidal Circular Stapler
  • Model / Serial
    PROXIMATE® HCS Hemorrhoidal Circular Stapler Code: PPH01 Lots : P9461W P94K20 PROXIMATE® PPH Hemorrhoidal Circular Stapler Code: PPH03 Lots: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9463J P94H5F P93W3M P94765 P94J4W P93W3N P9487Z P94J80 P93Y58 P94901 P94K2A P94117 P94A20 R9200Z PPH03-16 : P94901 P9420Z P94117 P9420Z P9420Y
  • Product Description
    Surgical Stapling
  • Manufacturer
    Ethicon Inc.

Manufacturer

Ethicon Inc.
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical Saudi Arabia Limited
  • Source
    SFDA