Events

Safety Alert for Examination Glove and Descarpack Procedure with Talc, Registration nº 80518310001, Sizes PP, P, M, G

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Descarpack Descartáveis do Nordeste Ltda; Top Glove SDN BHD.

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
    1357
  • Date
    2014-02-10
  • 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
    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forwarded a document stating that the suspension of the Authorization for the Use of the Conformity Identification Seal was revoked since the company carried out all corrective actions and was approved in the tests provided for in the Conformity Assessment Regulation.
  • Reason
    Suspension of the authorization for the use of the conformity identification seal by the product certification body (ocp) due to the failure of the semiannual maintenance tests, according to reports micl / l-240731/1/13 (proof) and mic / l-241647/1/14 (counter-proof), issued by the ocp ifbq.
  • Action
    Company should trigger Field Action. ////// UPDATE - 08/28/2014 - The company finalized the field action.

Device

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

Manufacturer

Descarpack Descartáveis do Nordeste Ltda; Top Glove SDN BHD
  • Source
    ANVSANVISA