Events

Recall of COSEAL Surgical Sealant 2ml and 4ml

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-2014-RN-00827-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00827-1
  • 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
    Out of specification results were observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. coseal's failure to gel does not represent a serious risk for the patient's life. all other stability requirements were met. the investigation into this issue is ongoing, and appropriate actions will be taken.
  • Action
    Baxter is requesting their customers to discontinue use of the affected lots. Baxter Customer Service can be contacted to arrange for the return of affected inventory. This action has been closed-out on 04/08/2016.

Device

COSEAL Surgical Sealant 2ml and 4ml
  • Model / Serial
    COSEAL Surgical Sealant 2ml and 4mlCOSEAL 2mlProduct Code: 934073COSEAL 4mlProduct Code: 934074Multiple lot numbers affectedARTG Number: 181132
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd