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 The Anspach Effort, 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 029 06 14 000
  • Event Initiated Date
    2014-06-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5955
  • 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
    The company identified through internal testing of sterrad® 100s sterilization process that several anspach attachments did not achieve the expected sterility assurance level (sal) of 10⁻⁶ .

Device

STERRAD 100S Hydrogen Peroxide Gas Plasma Technology (STERRAD® 100S) for sterilization.
  • Model / Serial
    DFU : 18-0047 Title : DFU, IMRI MOTOR Revisions : A & B DFU : 18-0074 Title : CLEANING & STERILIZATION DFU Revisions : A DFU : 18-0105 Title : CLEANING & STERILIZATION DFU Revisions : A Operating Manual: 0X6.001.506 Title : Anspach Pneumatic Systems User's Manual Revisions : AA Operating Manual: 0X6.001.507 Title : High Speed Electric User's Manual Revisions : AA, AB Operating Manual: 19-0010 Title : Anspach Pneumatic Systems User's Manual Revisions : A Operating Manual: 19-0013 Title : High Speed Electric User's Manual Revisions : A, B & C
  • Product Description
    CLEANING & STERILIZATION
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Al-Nozha Medical Est, (012) 6534664
  • Source
    SFDA