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.