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 Origio A/S.

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 044 09 14 000
  • Event Initiated Date
    2014-09-14
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=6429
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The manufacturer has identified that in some cases the outer needle of double lumen needles can become detached from the handle during oocyte retrieval and also the outer needle can be twisted around the inner needle. this can lead to an increase in discomfort including more bleeding than normal for the patient during the procedure.

Device

Follicle Aspiration Set/Oocyte Retrieval
  • Model / Serial
    Product Code: FASDL1 6G, DL 16035111, DL 16035141, DL 16035641 Affected Lot Numbers: 0911FAS DL16G01, 1211FASDL16G01, 0212FASDL16G01, 0412FASDL16G01, 0512FASDL16G01, 0712FASDL16G01, 1212FASDL16G01, 0113DL1603511101, 0213DL1603511101, 0213DL1603511102, 0313DL1603511101, 0413DL1603511101, 1112DL1603514101, 0313DL1603514101, 0213DL1603564101, 0513DL1603564101
  • Product Description
    Needle, aspirating oocyte, single use
  • Manufacturer
    Origio A/S

Manufacturer

Origio A/S