Events

Safety Alert for RENEGADE MICROCATETER - NV - 2009-255 - Registered in Anvisa under the number 10341350227. Models / Lots - see attached relation.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific 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
    985
  • Date
    2009-09-23
  • 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 product listing included in this "Voluntary Customer Gather Notification" provides a list of all UPN codes and affected lots, as well as their catalog numbers and expiration date range for those affected products. Based on our records, the attached Verification and Traceability Response Form contains product information for all affected products purchased by you. When inquiring whether you have affected product in your stock, please refer to your Verification and Traceability Response Form and the affected products listed in this Attachment Notice. Anvisa is following this action.
  • Reason
    It has been reported that the bag sealing (top sealing) may be broken. if a compromised sealing is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, septic endocartitis, organ failure, and death.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them in a safe place. (3) Complete and return the account verification and traceability response form to Boston Scientific do Brasil Ltda. - A / C Caroline Yin - Fax: (011) 5502-8510; (4) Pack, identify the box with affected products and request collection by calling (011) 5502-8583.

Device

RENEGADE MICROCATETER - NV - 2009-255 - Registered in Anvisa under the number 10341350227. Models...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA