Safety Alert for OMNICAN H MINHI NEEDLES 0.3 X 8 MM AND OMNICAN 0.30 X 8 MM

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by B. BRAUN MEDICAL LTDA.

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
    Safety alert
  • Event ID
    19
  • Date
    2001-10-18
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Occurrence of a high number of incidents associated with whippers for different lots of the product during the insulin administration with pre-loaded syringes. the insufficient or inefficient performance of the needles compors serious risks to the health of the diabetic population, for insufficient metabolic control of the disease.
  • Action
    COLLECTION OF ALL LOTS OF OMNICAN H MINHI NEEDLES 0.3 X 8 MM AND OMNICAN 0.30 X 8 MM WITHIN 10 DAYS

Manufacturer

  • Source
    ANVSANVISA