Events

Safety Alert for CATHETER FOR OXYGEN MARK MED - Record: 10207820020 - Type Glasses Nr. 2 - Risk Class II - Medium Risk - Technical Name: Respiratory circuits (LOT AFFECTED 3036 - Validity 11/2017)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MARK MED INDÚSTRIA E COMÉRCIO 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
    1453
  • Date
    2014-11-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The company must pay for the units in the market (lot 3036).
  • Reason
    Presence of foreign body - unsatisfactory result in the aspect test, according to the single sample fiscal analysis report no. 114.48259, issued by the central public health laboratory of bahia (lacen / ba).
  • Action
    Anvisa determined the suspension of distribution, trade and use, as well as the collection of lot 3036, pursuant to Resolution RE No. 3,227, of 08/21/2014, published in DOU No. 161 - Section 1 - page 51, of 08/22/2014, 2014. (SEE ATTACHED)

Device

CATHETER FOR OXYGEN MARK MED - Record: 10207820020 - Type Glasses Nr. 2 - Risk Class II - Medium ...

Manufacturer

MARK MED INDÚSTRIA E COMÉRCIO LTDA
  • Source
    ANVSANVISA