Events

Safety Alert for BARD HICKMAN / LEONARD / BROVIAC / / Technical name: Catheters /// ANVISA registration number: 10178010080 /// Hazard class: IV - Maximum risk /// Model: Hickman 9Fr /// Affected serial numbers: HUZB0322 and HUZB1750.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Politec Importação e Comércio Ltda.; BARD ACCESS SYSTEMS / BARD REYNOSA S.A DE C.V.

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
    2002
  • Date
    2016-09-14
  • 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 product must be segregated and returned to Politec Importação e Comércio Ltda. This recall does not affect any products consumed or patients with these implanted catheters.
  • Reason
    The expiration date of the needle, which is part of the bard hickman / leonard / broviac vascular access catveter kit, is not described in the product unit or in its labeling.
  • Action
    Field Action Code RA 151/16 triggered under the responsibility of the company Politec Importação e Comércio Ltda. Company is performing product recall.

Device

BARD HICKMAN / LEONARD / BROVIAC / / Technical name: Catheters /// ANVISA registration number: 10...

Manufacturer

Politec Importação e Comércio Ltda.; BARD ACCESS SYSTEMS / BARD REYNOSA S.A DE C.V
  • Source
    ANVSANVISA