Alerta De Seguridad para Application name: Applicator for laser surgery Technical Name: Applicators Registration Number ANVISA: 80058580020 Hazard Class: III Model Affected: CR-XXX, CA-XX-YYY, CB-XXX-YYY Serial Numbers Affected: laser model CA-30-250 with aspiration - Code 015093 - Lot 16 I 003 Applicator for laser surgery model CA-30-250 without aspiration - Code 015071 - Lot 16 I 002

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.

Guidelines for regulated entities at any level: • Segregate and discontinue use of models and batches of products under this recall. • Check your inventory to determine if you own any of the products listed above. • If you have already sold some or all of the products, contact your customer and require their traceability for the affected products. It is reinforced that the return and full communication of traceability of the requested products is obligatory, according to the bond of joint responsibility, which is formed when the products are supplied to customers. To return the products, please call the Customer Service at (0xx16) 3306-5050, to inform the details of the product that will be returned.