Events

Recall Or Safety Alert for ECHELON Endoscopic Linear Cutter Reloads Black (ECR60T)

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Ethicon Endosurgery LLC.

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
    Recall / Safety Alert
  • Event ID
    31-1054-MD/2011
  • Date
    2013-12-10
  • Event Country
    India
  • Event Source
    CDSCO
  • Event Source URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alerts
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 recall data from the U.S. and India.
  • Extra notes in the data
  • Reason
    Recall of "echelon endoscopic linear cutter reloads black (ecr60t)" due to the potential for incomplete staple line formation from reload damage during firing sequence which may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.

Device

ECHELON Endoscopic Linear Cutter Reloads Black (ECR60T)
  • Model / Serial
    ECR60T, lot: J4AY8Z, J4CC1F, J4CJ78, J4CM9X, K4C94W, K4CC0L, K4CF5D
  • Manufacturer
    Ethicon Endosurgery LLC

Manufacturer

Ethicon Endosurgery LLC