Events

Safety Alert for Endoscopic Linear Cutter Reload, Black, Record no. 80145900883. Range of expiration date affected: 05-2013 to 03-2014. Lots: See attachment

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1287
  • Date
    2013-05-29
  • 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 reports that the event found may result in insufficient tissue apposition and may require surgical intervention to help achieve and maintain anastomotic integrity. To date, the company is not aware of any potential complications that have occurred as a result of this event
  • Reason
    The registrant reports that ethicon endo-surgery is initiating a voluntary recall of batches listed in the annex due to potential for incomplete stapling line formation caused by damage to recharge during the firing sequence.
  • Action
    The company provided the following guidance: 1. Inspect your inventory immediately to verify that you have the affected product manufactured by Ethicon and remove it from the stock (see attachment). 2. Fill out the Business Response Form (BRF) and fax to the local company within 11 working days, even if you do not have the product affected. The company requests that you mention Event 4706. If you have any product to be returned, keep a copy of this form in your records. The replacement product will be shipped in lieu of all recalled products that are returned. 3. All affected products must be returned by August 30, 2013 to receive the replacement product. To return the affected product, take a xerox copy of the completed Business Response Form, put it in the box along with your product. 4. The ECHELON 60mm Black Reload (ECR60T) products will be replaced by the corrected ECHELON 60mm Black Reload (ECR60T) as soon as the supply is made available. 5. If you do not have the affected product in inventory, you must still complete and return the Business Response Form, stating that you do not have any affected products. 6. We ask that you share this information with all appropriate personnel at your facility. 7. If you need assistance identifying an alternate product code, please contact your Ethicon Sales Representative directly.

Device

Endoscopic Linear Cutter Reload, Black, Record no. 80145900883. Range of expiration date affected...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda