Recalls and suspensions

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18 November 2021
Device repair/replacement program has commenced
14 September 2021
Recall due to risk of bacterial contamination
2 August 2021
Recall - Possible presence of benzene
3 June 2021
Product Defect Alert - child-resistant caps may not function correctly

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Safety information

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25 November 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.
18 November 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.
11 November 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.
9 November 2021
TGA investigation – potential contamination of medicines with nitrosamine impurities

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News

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26 November 2021
TGA decision: Rholistiq (belumosudil mesilate) is approved to treat chronic graft-versus-host disease (GVHD)
26 November 2021
This guidance applies to manufacturers of medical devices that are regulated as 'system or procedure packs' and supplied using the special conformity assessment procedure regulatory pathway.
26 November 2021
Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs
26 November 2021
New guidance on the regulation of first aid kits and using the special conformity assessment procedure.

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