Alerta De Seguridad para BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II, lots: REWL0924, REXA1695, REXB1529, REXC1632.

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.

The potential risk associated with attempting to proceed with coaxial placement, using the sharpened stylus rather than the optional blunt tip stylus, may be variable depending on the anatomical location of the biopsy and may cause an additional unintended risk to tissue, vessels and other organs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.