Events

Safety Alert for Name of the product: ANGIOGRAPHIC CATETER IMAGER II (SELECTIVE) Technical name: ANVISA registration number: 10341350453 Hazard class: IV Model affected: M001314141; M001314231; M001314321; M001314331; M001314351; M001314661; M001314671; M001315111; M001314111; M001314241; M001316871

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; Teleflex Medical.

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
    2198
  • Date
    2016-12-21
  • 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
    1. Post this information immediately in a location visible near the product to ensure that this information is easily accessible to all users of the device. The. If you identify any product in your inventory without the lower seal of the primary packaging: Discontinue use immediately and segregate the product. B. Immediately remove all affected products from your inventory. w. Segregate this product in a safe place for return to Boston Scientific. d. Immediately contact Boston Scientific to obtain a Returned Goods Authorization Number (RGA). When contacting BSC, please include your customer number, UPNs and shipment (s) affected, and quantities: Email: calidad@bsci.com 2. Complete and return the Receipt Confirmation Form. Complete the attached Receipt Confirmation Form (even if you do not already own any of the products) by following the instructions on this page and the form. Return the Receipt Confirmation Form to: Email: calidad@bsci.com
  • Reason
    Boston scientific is launching a product alert for a subset of imager ™ ii angiographic catheters. after a field report, boston scientific has determined that some units in a single batch do not have the sealing wrap inside. this was caused by an alternative label reprint process, which resulted in the absence of a step in the packaging process of the units. although boston scientific has confirmed that only one shipment has the missing seal, we are, as a precaution, notifying all customers who received shipments processed through this alternative label reprint process.
  • Action
    Field Action Code 92042226 triggered under the responsibility of Boston Scientific do Brasil Ltda. Company will make informational to customers.

Device

Name of the product: ANGIOGRAPHIC CATETER IMAGER II (SELECTIVE) Technical name: ANVISA registrati...

Manufacturer

Boston Scientific do Brasil Ltda; Teleflex Medical
  • Source
    ANVSANVISA