Events

Safety Alert for Key Empirical Dynamometer, Registration 80136990682, Lot / Series 51643928, 51644510, 51653452, 51672690 and 51809478

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; Aesculap AG.

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
    1631
  • Date
    2015-07-06
  • 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
    According to the manifestation of the company, the purpose of this communication is to prevent occurrences of product breakdown.
  • Reason
    The company informs that the release mechanism of the torque switch supports the application of a defined force of 2.8nm. if the applied force is greater than the defined force, the screw break may occur. the torque wrench is made up of three parts and can be dismantled for cleaning. assembly and disassembly of the torque switch are described in the product use manual.
  • Action
    The company instructs you to follow the assembly and disassembly instructions described in the Product Use Manual and detailed in the Appendix - Customer Letter.

Device

Key Empirical Dynamometer, Registration 80136990682, Lot / Series 51643928, 51644510, 51653452, 5...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG