2023-10-20T06:47:07
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.
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