Events

Recall of Ethicon Mersilene Tape (intended for use in circular suture of the cervix)

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-2016-RN-01042-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01042-1
  • 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
    Some mersilene tape product codes have been supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this issue have being supplied with a mersilene suture ifu. the indications for mersilene suture are different from the indications for mersilene tape.
  • Action
    Johnson & Johnson are advising users to examine their inventory immediately to determine if they have affected product, and are providing the correct IFU for MERSILENE Tape.

Device

Ethicon Mersilene Tape (intended for use in circular suture of the cervix)
  • Model / Serial
    Ethicon Mersilene Tape (intended for use in circular suture of the cervix)Product Codes: RS21, RS22, D9212All unexpired lotsARTG Number: 165076
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd