Safety Alert for LANCETAS SFL YELLOW 2.2X1.0mm - MICROTAINER BRAND SAFETY FLOW LANCETS BDLANCETA MICROTRAINER. II - MEDIUM RISK, Reg. ANVISA: 10033430270 - Lots: 2319394, 3069725, 3149410 and 3213535.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson and Company.

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
    896
  • Date
    2007-11-27
  • 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
    Upon failure of the anti-reuse device, the lancet blade may be exposed during disposal. Note: manufacture of this product was discontinued in 2003. The last sale in Brazil occurred in 2004 and the registration of the product with ANVISA was valid until the year 2005. The product in question is not intended for home users, only hospitals and clinics According to the company there were no reported problems with the lots involved in Brazil and that the collection of this product 3 years after the closure of sales is preventive. For further information contact the BD Technical Center, through the Telephone. 0800.055.5654.// Update: On January 23, 2008 the company reported that 38 customers received the product and that all were informed of the recall, of which 24 stated they did not have any unit of the lots involved in stock. They also reported that this recall was released in the media (newspaper, radio and television) in November 2007.
  • Reason
    Limited number of reports of device-trigger device crash. access the lots: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/896.Pdf.
  • Action
    Voluntary pickup with mailing for all customers requesting that the use of the product be interrupted and the remaining quantities are returned to the company.

Manufacturer

  • Source
    ANVSANVISA