PRA number
2019/17822
Published date
Product description
Alpha Conducting Solution (ACS) 15mL used with Alpha-Stim M and AID devices
Manufactured between June 2014 and October 2018
Lot Numbers 081914-15, 111715-15, 070116-15, 020117-15, 080117-15, 010118-15, 041618-15, 071618-15, 102018-15
Alpha Conducting Solution Replacement (ACSR) 250mL used with Alpha-Stim M and AID devices
Manufactured between February 2014 and October 2018
Lot numbers 032014-25, 060515-25, 101615-25, 011716-25, 020117-25, 080117-25, 010118-25, 041618-25, 071618-25, 102018-25
ARTG 185395
(Pureplay Orthopaedics - gel, electrode)
Manufactured between June 2014 and October 2018
Lot Numbers 081914-15, 111715-15, 070116-15, 020117-15, 080117-15, 010118-15, 041618-15, 071618-15, 102018-15
Alpha Conducting Solution Replacement (ACSR) 250mL used with Alpha-Stim M and AID devices
Manufactured between February 2014 and October 2018
Lot numbers 032014-25, 060515-25, 101615-25, 011716-25, 020117-25, 080117-25, 010118-25, 041618-25, 071618-25, 102018-25
ARTG 185395
(Pureplay Orthopaedics - gel, electrode)
Reasons the product is recalled
The product may not effectively control microbial contamination.
The contamination, if present, will not be readily visible to the naked eye.
The contamination, if present, will not be readily visible to the naked eye.
The hazards to consumers
Microbial contamination may cause injury or illness.
What consumers should do
Consumers should immediately cease using the product and contact Pureplay to arrange a replacement product.
For more information, consumers should contact Pureplay Orthopaedics Customer Service on 03 9888 8808.
For more information, consumers should contact Pureplay Orthopaedics Customer Service on 03 9888 8808.
Supplier
Where the product was sold
New South Wales
Queensland
South Australia
Tasmania
Victoria
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.