Events

Recall of Omrix Pressure Regulators (used to spray Evicel Solutions for Fibrin Sealent during open and laproscopic procedures to prevent bleeding)

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-00320-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00320-1
  • 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
    The european medicines agency (ema) has clarified their recommendation for 20 psi (as opposed to 20-25 psi) pressure to be used when spraying evicel with the 45cm tip during laparoscopic surgery. as a result, the labelling of omrix pressure regulators in australia need to be updated and the sticker label on each pressure regulator will be replaced to reflect this change.Also, in an effort to enhance consistency between the labelling of the omrix pressure regulator and the omrix evicel solutions for sealant, the ifu for the pressure regulator has been updated to remove the following statement;"spray application of evicel should not be used in endoscopic procedures where the minimum recommended distance of 4 cm cannot be maintained. for laparoscopic procedures using accessory tips, see the recommendations in table 2".
  • Action
    Johnson & Johnson Medical (JJM) is providing users with the updated IFU and replacing stickers on the Omrix Pressure Regulators to reflect the new recommendation of 20psi when spraying Evicel with a 45cm tip during laparoscopic surgery. This action has been closed-out on 30/01/2017.

Device

Omrix Pressure Regulators (used to spray Evicel Solutions for Fibrin Sealent during open and lapr...
  • Model / Serial
    Omrix Pressure Regulators (used to spray Evicel Solutions for Fibrin Sealent during open and laproscopic procedures to prevent bleeding)Product Number: EVRC68 AND EVR54CARTG Number: 203072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd