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)
See a list of details to help identify the product.
Reason 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.
Details to help identify the product.
Supplier running the recall
Who sold the product
26 Associations and Hospitals
Identifying product features
Identifying numbers
Other identifying numbers
See attached list
Where the product was sold
Nationally
International
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2019/17816 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.