Alerta De Seguridad para STERILE DISCHARGEABLE SYRINGE WITHOUT NEEDLE 60 ML. Reg. ANVISA: 10033430371. Catalog Number: 309653. Lots Affected: Check the list available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_934_Lotes_Afetados.pdf

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.

BD Ltda has decided to take a corrective action due to the observation that, at low atmospheric pressures (observed at altitudes above 2,438 meters), the syringe packaging of the aforementioned lots can open and cause contamination of the product. According to the company, there was no market complaint regarding problems with the integrity of the sealing of the unit packaging of the product. To access the company's communication letter, access the electronic address: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_934_carta_Comunicacao_Clientes.pdf