Dentsply Sirona Pty Ltd — LoFric 40cm CH12 Nelaton Catheter

PRA number

2018/17150

Published date

Product description

LoFric 40cm CH12 Nelaton Catheter
Urethral catheter, drainage, single-administration

ARTG Number: 204668
Identifying features

Other identifying numbers

Lot Number 18192

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.

Where the product was sold

New South Wales
Queensland
Victoria

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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