Events

Safety Alert for Harvest Graft Applicator. Anvisa Registry No. 80012280129. Affected lots: GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053 , GDP-10-0054, GDP-10-0055, GDP-10i-0010.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Harvest Technologies Corp..

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
    1294
  • Date
    2013-09-24
  • 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
    According to information submitted by Terumo, a risk assessment was conducted and, based on this investigation, the management of Harvest Technologies Corp. (manufacturer) concluded that the following batches of GDP-10 were affected and should be collected: GDP-10-0046 , GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP -101-0010. Of these lots, only lot GDP-10-0048 was distributed in Brazil.
  • Reason
    The device's luer connector may be broken and may cause leakage of biological material during the procedure.
  • Action
    Products at risk identified should be segregated and returned to Terumo Medical of Brazil. Additional information should be checked at: http://portal.anvisa.gov.br/wps/wcm/connect/610aec80413743c384a68fa8d08ea2d4/Carta_ao_Cliente.pdf?MOD=AJPERES

Device

Harvest Graft Applicator. Anvisa Registry No. 80012280129. Affected lots: GDP-10-0046, GDP-10-004...

Manufacturer

Harvest Technologies Corp.