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.

See a list of details to help identify the product.

Reason 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.

The hazards 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.

Details to help identify the product.

Supplier running the recall

Who sold the product

Healthcare equipment retailers and mobility and rehabilitation services

Dates available for sale

-

Where the product was sold

New South Wales
Victoria

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2020/18606 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.