PRA number
2020/18606
Published date
Product description
DM36 Dreama Slim Support Pad for Jenx Dreama Sleep Mattress
Product Code: 7120-3240-000
Manufactured between November 2019 and September 2020
ARTG 261614
(Medifab Ltd - Positioning aid system)
This product was previously the subject of a recall on 8 July 2020 (PRA2020/18418) for a defect in a different part.
Product Code: 7120-3240-000
Manufactured between November 2019 and September 2020
ARTG 261614
(Medifab Ltd - Positioning aid system)
This product was previously the subject of a recall on 8 July 2020 (PRA2020/18418) for a defect in a different part.
Why the product is recalled
The inserts that attach the small PU pad to the bracket are manufactured from plywood sheet material that may contain structural defects. This reduces the strength of the fitting, which can result in the plywood splitting and the support pad breaking off the bracket.
Breakage may occur without warning and the affected items cannot be easily identified upon inspection.
Breakage may occur without warning and the affected items cannot be easily identified upon inspection.
What the hazards are to consumers
There is a risk of injury if the affected items breaks while in use.
What consumers should do
Immediately cease using the affected item. Medifab will contact affected consumers in writing to arrange for replacement part to be fitted.
Only the identified part is required to be removed, any other Dreama system components remain safe for use.
For further information, contact Medifab on 03 6427 0105.
Only the identified part is required to be removed, any other Dreama system components remain safe for use.
For further information, contact Medifab on 03 6427 0105.
Supplier
Traders who sold this product
Healthcare equipment retailers and mobility and rehabilitation services
Where the product was sold
New South Wales
Victoria
Dates available for sale
-
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.