Alerta De Seguridad para INJEX WRINKLE SYRINGE SYMBOLS WITHOUT NEEDLE, Registration No. 10160610007, lot: 4897, FAB. 08/2010, VAL 07/2015

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 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.