PRA number
2021/18942
Published date
Product description
Westlab Reusable Medical Face Shield
Product Code: 664-182
ARTG 333131 (WESTLAB PTY LTD - Shield, face - Single-use devices)
Product Code: 664-182
ARTG 333131 (WESTLAB PTY LTD - Shield, face - Single-use devices)
What are the defects?
The Instructions for Use (IFU) have been updated to include additional wording:
For protection against airborne particles that may be present in the environment due to aerosol-generating procedures (AGP), Westlab recommends wearing a face mask and/or safety eyewear for additional protection.
For protection against airborne particles that may be present in the environment due to aerosol-generating procedures (AGP), Westlab recommends wearing a face mask and/or safety eyewear for additional protection.
What are the hazards?
If airborne particles are present in the environment and the face shield does not fully protect the user against exposure to those particles, this may lead to serious illness.
What should consumers do?
Westlab will contact affected consumers in writing.
For additional protection against airborne particles, users are advised to follow the updated instructions for use and wear a face mask and/or safety eye ware when using the Westlab Reusable Medical Face Shield.
For further information, please contact Westlab Customer Service on 1800 358 101.
For additional protection against airborne particles, users are advised to follow the updated instructions for use and wear a face mask and/or safety eye ware when using the Westlab Reusable Medical Face Shield.
For further information, please contact Westlab Customer Service on 1800 358 101.
Supplier
Traders who sold this product
Healthcare and Personal Protection Equipment (PPE) suppliers
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.