Product description

Alpha Active 3, Alpha Active 4 and Alpha Active 5 medical pumps

ARTG 288608
(Arjo Australia Pty Ltd - Alternating-pressure bed mattress overlay system)

See a list of details to help identify the product

Reason the product is recalled

The mains cables may become damaged through incorrect stowage or misuse.

The hazards to consumers

If the mains cables have been damaged, this can result in electric shock, which can cause serious injury or death.

What consumers should do

Arjo Australia will contact affected consumers in writing. This issue will be rectified by increasing the cable wall thickness and incorporating an improved grommet.

Consumers should:

1. Verify whether they possess any Alpha Active 3, Alpha Active 4 or Alpha Active 5 pumps and ensure that all caregivers and users are made aware of this issue.

2. Make sure the cable is disconnected from the power socket and then check carefully all electrical connections for signs of damage or excessive wear. If any damage is observed, remove the device from use and contact Arjo Australia.

3. The device can remain in use as long as the cable is not frayed or worn and is secured properly to prevent being caught or entrapped in the bed mechanism as advised in the Instruction for Use.

For further information, consumers can contact Arjo Australia on 1800 072 040.

Details to help identify the product

Supplier running the recall

Identifying product features

Identifying numbers

Other identifying numbers

See attached serial number 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 2021/18792 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.