Events

Safety Alert for Coseal Surgical Sealant

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare Ltd.

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
    Safety alert
  • Date
    2011-07-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110727.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Alert on product recall: coseal surgical sealant baxter healthcare ltd is voluntarily recalling one lot of coseal surgical sealant (product code: 934074, lot no. ha090947, with expiry date 08/31/11) as a precautionary measure. one parameter of the device in the manufacturer’s stability test is found to be out of specification and there is possible failure for the product to gel appropriately. the manufacturer claimed that such failure does not represent risk for patient’s life. the manufacturer further asked the users to stop using the above lots and to quarantine any units that may be put in the users’ inventory. if the product cannot gel appropriately, users may use of a second kit of product or alternative method for hemostasis. the measures have been described in the ifu of the device. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Coseal Surgical Sealant
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [27 Jul 2011] Coseal Surgical Sealant
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd