PRA number
2021/18792
Published date
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)
ARTG 288608
(Arjo Australia Pty Ltd - Alternating-pressure bed mattress overlay system)
Reasons 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.
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.
Supplier
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.