Alerta De Seguridad para Examination Glove and Descarpack Procedure with Talc, Registration nº 80518310001, Sizes PP, P, M, G

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 semi-annual maintenance tests indicated that the sample analyzed does not meet the microbiological requirements of INMETRO Ordinance no. 322 of June 26, 2012. The health services that have the product in stock must segregate the samples so that the registry holder can proceed with the collection. All batches marketed as of April 2013, the date of the last maintenance assessment of the conformity identification seal, shall be segregated. //////// UPDATE - 08/28/2014 - The company sent a report of completion of the field action. According to the company, all customers were communicated by telephone, e-mail and letter with AR. Of the total customers who purchased the glove, 37.67% returned with information, of which 8.97% had the gloves in stock, and 2.91% of the glove sold were collected.//// 11/25/2014 - IFBQ forwarded a document stating that the suspension of the Authorization for the Use of the Conformity Identification Seal was revoked since the company carried out all corrective actions and was approved in the tests provided for in the Conformity Assessment Regulation.