Events

Safety Alert for Trade Name: APPLICATOR OF LAPAROSCOPIC CLIPS AND CARTUCHOAPPLIED MEDICAL - Reg. 10334020024 - Class III-high risk; Model: CA090; Lots 1253273; 1241859; 1218682; 1228667; 1203554; 1250211; 1247895; 1237567; 1207745; 1211038.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AMETECH TRADING LTDA.; APPLIED MEDICAL RESOURCES 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
    1897
  • Date
    2016-05-13
  • 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
    Contact Ametech Tranding Ltda: phone 41-3353-2004
  • Reason
    The manufacturer has received a number of technical complaints regarding dry tripping of the clips and short power supply of the ca090 since 2013. as a result, it was decided to recall all units manufactured since 2013.
  • Action
    RGA action code # 60698158. Letter orientation to clients /////// Gathering.

Device

Trade Name: APPLICATOR OF LAPAROSCOPIC CLIPS AND CARTUCHOAPPLIED MEDICAL - Reg. 10334020024 - Cla...

Manufacturer

AMETECH TRADING LTDA.; APPLIED MEDICAL RESOURCES CORP.
  • Source
    ANVSANVISA