Events

Safety Alert for BD VACUTAINER PLASTIC TUBE WITH REAGENT FOR VACUUM BLOOD COLLECTION - Registration 10033430470 - Model Tube Vacutainer Citrate (9NC) 0,109M Cap Hemogard 2.7ml. - Lot Affected: 2180434 - val. Apr / 2013.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Indústrias Cirúrgicas 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
    1212
  • Date
    2012-12-06
  • 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
    See attached Letter to the Client. Anvisa follows this Field Action. http://portal.anvisa.gov.br/wps/wcm/connect/9883f9804db6d3d6af54bfd6059e5711/Carta_ao_Cliente_1212.pdf?MOD=AJPERES #### UPDATE: 06/03/2013 - The company announces the CLOSURE of the field action. # ###
  • Reason
    Possible lithium heparin contention.
  • Action
    Immediately discontinue use of the affected product. Locate the affected product in stock and segregate for later recall by the record holder.

Device

BD VACUTAINER PLASTIC TUBE WITH REAGENT FOR VACUUM BLOOD COLLECTION - Registration 10033430470 - ...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.
  • Source
    ANVSANVISA