Pureplay Orthopaedics — Alpha Conducting Solution (ACS) 15mL and Alpha Conducting Solution Replacement (ACSR) 250mL used with Alpha-Stim M and AID Devices

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)
Identifying features

Other identifying numbers

ACS Lot Numbers 081914-15, 111715-15, 070116-15, 02017-15, 080117-15, 010118-15, 041618-15, 071618-15, 102018-15 and ACSR Lot Numbers 032014-25, 060515-25, 101615-25, 011716-25, 020117-25, 080117-25, 010118-25, 041618-25, 071618-25, 102018-25

What are the defects?

The product may not effectively control microbial contamination.

The contamination, if present, will not be readily visible to the naked eye.

What are the hazards?

Microbial contamination may cause injury or illness.

What should consumers 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.

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.

Product category