PRA number
2019/17816
Published date
Product description
Various Convex Two-Piece Skin Barriers
Natura, Surfit and Combihesive Wafers
Manufactured between February 2017 to September 2018
ARTG 235593
(Convatec Australia Pty Ltd - Ostomy base plate, convex)
Natura, Surfit and Combihesive Wafers
Manufactured between February 2017 to September 2018
ARTG 235593
(Convatec Australia Pty Ltd - Ostomy base plate, convex)
Reasons the product is recalled
On the Convex Two-Piece Skin Barriers, the starter hole (stoma hole) is off-centre.
The hazards to consumers
If the starter hole (stoma hole) is off-centre it can cause cuts to the skin, resulting in injury to the user.
What consumers should do
Consumers should inspect stock and verify whether units have an off centre starter hole (stoma hole). If you have any product you have identified as off-centre in your possession, please contact the ConvaTec Help Desk. ConvaTec will accept product returns and replace affected product free of charge.
For further information, contact the ConvaTec Help Desk on 1800 339 412.
For further information, contact the ConvaTec Help Desk on 1800 339 412.
Supplier
Traders who sold this product
26 Associations and Hospitals
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.