Events

Safety Alert for INJEX WRINKLE SYRINGE SYMBOLS WITHOUT NEEDLE, Registration No. 10160610007, lot: 4897, FAB. 08/2010, VAL 07/2015

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by INJEX INDUSTRIAS CIRURGICAS LTDA.

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
    1475
  • Date
    2014-11-17
  • 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 company clarifies that lot 4897 manufactured in 08/2010 had 525,000 units shipped. With validity of 60 months, remaining only 9 months to maturity. Therefore, the aforementioned lot has already fulfilled 85% of its useful life in the market and to date there has been no complaint regarding it. After the recall of the market units and identification of the origin of the foreign body found in the package, a detailed investigation of the type of problem will be carried out, identifying its origin, corrective and preventive actions necessary to avoid new occurrences and guarantee the manufacturing process according to the Good Manufacturing Practices .///// UPDATE 13/01/2015: COVISA NOTICE Nº. 106/2014 - The Health Surveillance Coordination - COVISA / SMS, determines as a measure of health interest, the prohibition of the product Disposable Syringe Luer Lock Nozzle 3 mL, without needle, Injex brand, Anvisa Registration 10160610007, lot 4897, manufacture 08 / 2010, valid for 5 years, manufactured by Injex Indústrias Cirúrgicas Ltda, CNPJ: 59.309.302 / 0001-99 in establishments in the city of São Paulo. The interdiction by SUVIS / COVISA of that batch of the product; Collection by the manufacturer of all units of the product in question. The Coordination of Health Surveillance / SMS makes available to consumers and interested companies, the telephone 11-3397-8280, 3397-8279, e-mail: smscovisa@prefeitura.sp.gov.br, so that using their rights communicate the presence of said product.
  • Reason
    Published in the official gazette of the city of são paulo n ° 59 (208), by the health surveillance coordination, health surveillance products and services management; sub-management of products; covisa notice no. 091/2014 of provisional interdiction of the product disposable syringe luer lock nozzle, without needle, lot 4897, referring to the presence of foreign body in inviolate packaging.
  • Action
    The company is collecting the product and requests the users and patients to keep the lot segregated, until collection and replacement by Injex.

Device

INJEX WRINKLE SYRINGE SYMBOLS WITHOUT NEEDLE, Registration No. 10160610007, lot: 4897, FAB. 08/20...

Manufacturer

INJEX INDUSTRIAS CIRURGICAS LTDA