Events

Recall Or Safety Alert for Omnifuse and Omnifuse PCA Syringe Pumps

According to Ministry of Health Malaysia, this recall or safety alert involved a device in Malaysia that was produced by Smiths Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety alert
  • Event Country
    Malaysia
  • Event Source
    MHM
  • Event Source URL
    https://portal.mda.gov.my/
  • Notes / Alerts
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Extra notes in the data
    Alert: Omnifuse and Omnifuse PCA Syringe Pumps (“Omnifuse Pumps”)1. Letter from MDB 2. Customer Information Bulletin 2015 3. Field Safety Notice 4. MEDDEV FSCA Report Form 5. Response Form 6. Risk Review Analysis Summary

Device

Omnifuse and Omnifuse PCA Syringe Pumps

Manufacturer

Smiths Medical