Events

Safety Alert for SANRO SURGICAL SURGICAL GLOVE - Reg. 1017048003; SURGICAL GLOVE SANRO TEX 10170480013; SANRO LIS SURGICAL GLOVE - Reg. 10170480014. 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
    1064
  • 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 scope of the Brazilian Conformity Assessment System (SBAC).
  • Reason
    Failure to perform annual maintenance tests, as demonstrated by the mechanical test reports ela / l-207.165 / 1/2/3/11 (test) and ela / l-208.428 / 1/2/3/11 (counter-test).
  • Action
    All products relating to these models must be segregated for destruction.

Device

SANRO SURGICAL SURGICAL GLOVE - Reg. 1017048003; SURGICAL GLOVE SANRO TEX 10170480013; SANRO LIS ...

Manufacturer

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