Recall Action Commencement Date: The date the reca...

Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA. vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions. viii Reason / Issue: Reason for the recall action. ix Recall Action: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are four distinct recall actions – recall, product defect correction, hazard alert and product defect alert. Recall - The permanent removal of an affected therapeutic good from supply or use in the market. Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The corrective action may take place at the user's premises or any other agreed location. Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an implanted medical device or biological product and advice about the ongoing management of patients. Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice to reduce potential risks of using affected goods. x Recall Action Instructions: What customers with affected goods should do. xi Contact Information: Who the customer should contact for additional information and clarification regarding the recall action.