International Medical Devices Database

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 084 02 12 000
Event Initiated Date
2012-02-14
Event Country
Saudi Arabia
Event Source
SFDA
Event Source URL
https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1415
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 devices are being recalled due to a potential contamination that could cause embryo degeneration at day 5/ 6. additional testing by the manufacturer on recently manufactured batches of culture oil showed a peroxide level that a literature report suggests could cause embryo degeneration.

Device

In vitro fertilization culture medium kit

Model / Serial
K-SICO & K-SICO, Sydney IVF Culture Oil, (K-StCO-200), (K-SrCO-50) Lot Numbers: attached
Product Description
In vitro, Oil, kit
Manufacturer
Cook Medical

Manufacturer

Cook Medical

Manufacturer Parent Company (2017)
Cook Group Incorporated
Manufacturers representative
Gulf Medical Co.
Source
SFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

What is this?

Device

In vitro fertilization culture medium kit

Manufacturer

Cook Medical