PRA number
2018/17150
Published date
Product description
LoFric 40cm CH12 Nelaton Catheter
Urethral catheter, drainage, single-administration
ARTG Number: 204668
Urethral catheter, drainage, single-administration
ARTG Number: 204668
Reasons the product is recalled
Some urethral catheter boxes have been incorrectly labelled.
The hazards to consumers
The user may insert the incorrect catheter into a patient due to mislabelling on the box. This could lead to the wrong insertion angle, with a possible result of minor bleeding/trauma.
What consumers should do
Dentsply Serona is advising customers to inspect stock for lot 18192 and identify any units that may experience this labelling anomaly.
In the event impacted stock is identified, consumers are requested to contact the Customer Care Nurses on 1800 622 492 to arrange return and replacement.
In the event impacted stock is identified, consumers are requested to contact the Customer Care Nurses on 1800 622 492 to arrange return and replacement.
Supplier
Where the product was sold
New South Wales
Queensland
Victoria
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.