Events

Safety Alert for SLEEVE FOR NON SURGICAL PROCEDURE AMBI TEX STERILE AND NON-STERILE - Reg. 10170480010; GLOVE FOR NON-SURGICAL PROCEDURE AMBI EX - Reg. 10170480011; SLEEVE FOR NON SURGICAL PROCEDURE SANRO AMBI TEX NON-STERILE - Reg. 10170480015. - ALL LOTS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fábrica de Artefatos de Látex São Roque S/A.

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
    1065
  • Date
    2011-07-01
  • 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 DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the (SBAC).) ### UPDATE - 12/01/2012 - The Certification body communicates that the corrective actions were satisfactory, granting new Authorship for Use of the Conformity Identification Seal. #
  • Reason
    Annual maintenance tests as shown in the mechanical test reports ela / l-207.160 / 3/4/5/6/11 (evidence) and ela / l-208.433 / 1/2/3/4/11 -proof).
  • Action
    All products relating to these models must be segregated for destruction.

Device

SLEEVE FOR NON SURGICAL PROCEDURE AMBI TEX STERILE AND NON-STERILE - Reg. 10170480010; GLOVE FOR ...

Manufacturer

Fábrica de Artefatos de Látex São Roque S/A
  • Manufacturer Parent Company (2017)
    Sotex Ltda.
  • Source
    ANVSANVISA