Events

Recall of LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00396-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00396-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Johnson & johnson pty ltd has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure.
  • Action
    End users are requested to immediately check their inventory to determine if their facility holds any affected units. Affected units must be quarantined until returned to Johnson & Johnson Pty Ltd.

Device

LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier)
  • Model / Serial
    LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier) Product Code: ER320Expiration Date: 2016-11 to 2018-03Kits containing ER320 Multiple kit product numbers and descriptions ARTG Number: 122810
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd