Events

Safety Alert for Product trade name: STERILE HYPODERMIC SYRINGE FOR SINGLE USE WITH NEEDLE DL /// Registration number: 80511919003 /// Affected model: 3 and 5 mL /// affected lot: 1408-05 and 1408- 01 / / Product hazard class: II

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DLP MEDICAL DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; DL MÉDICA S.A DE C.V.

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
    1884
  • Date
    2016-05-06
  • 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
    In case of remaining stock, inform the company and carry out its guidelines.
  • Reason
    The various non-conformities indicated by the reports that led to the suspension of the quality certificate could pose a risk to users, by which, as soon as we become aware./// recommendation: immediately suspend the sale of the products as well as their use.
  • Action
    Risk classification: II /// Classification of the field action: recollection with subsequent destruction /// Field action code: not specified /// Recommendations to users and patients: suspension of distribution, commercialization and use of lots involved.

Device

Product trade name: STERILE HYPODERMIC SYRINGE FOR SINGLE USE WITH NEEDLE DL /// Registration num...

Manufacturer

DLP MEDICAL DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; DL MÉDICA S.A DE C.V
  • Source
    ANVSANVISA