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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00827-1
Product Name/Description COSEAL Surgical Sealant 2ml and 4ml

Product Code: 934073

Product Code: 934074

Multiple lot numbers affected

ARTG Number: 181132
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/07/2014
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.
Contact Information 02 9848 1111 - Baxter Healthcare