Events

Safety Alert for 5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87, date of manufacture 03/2012, expiration date. 03/2017.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Descarpack Descartáveis do Brasil 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
    1277
  • Date
    2013-07-29
  • 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 states that the foreign body identified in the syringe was in the packaging of the product, not in its interior, pointing out possible problem in the packaging process (referring to the use of personal protective equipment - PPE).
  • Reason
    According to the cvs - 40 - gt correlatos / ditep communiqué, dated april 22, 2013, the adolfo lutz institute issued the 1743.00 / 2013 analysis report and the single sample tax analysis expert report, with an unsatisfactory conclusion in the appearance (foreign body presence) for the product disposable syringe 5ml disposable descarpack, luer lock nozzle, registration no. 10330669025, lot: sslloo87, date of manufacture 03/2012, expiration date 03/2017.
  • Action
    The company is collecting the product and asks users and patients to inform the SAC of the company, if they identify this lot of the product, by telephone (11) 3649-5555 and e-mail: sac.sc@descarpack.com .br ///////// UPDATE - 06/02/2014 - The company sent documentation informing about the completion of the field action and destruction of the collected units.

Device

5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87,...

Manufacturer

Descarpack Descartáveis do Brasil Ltda