Events

Safety Alert for DISTRIBUTOR TAP GABMED - 3 taps - 500 PSI-ON - Model HD-04030 - registration 10216830034 - Affected batches 10K07; 10K19; 11A27; 11B03; 11B04; 11C09.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Gabmed Produtos Específicos 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
    1144
  • Date
    2012-06-25
  • 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 states that in 2010 its supplier changed the formulation of lubricating oil without informing them. Such changes can cause multiple cracks after 6-12 months, some manifolds have performed well so far. This problem only happened in the manifold manufactured in 2010, since the beginning of 2011 has been changed to another type of lubricating oil. Anvisa is following this action.
  • Reason
    Product has small cracks in its extension.
  • Action
    To users, immediately stop the use of the affected product, check the batches of the affected product in its stock and segregate, contact the manufacturer to arrange the collection.

Device

DISTRIBUTOR TAP GABMED - 3 taps - 500 PSI-ON - Model HD-04030 - registration 10216830034 - Affect...

Manufacturer

Gabmed Produtos Específicos Ltda.