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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00807-1
Product Name/Description General Purpose 9 French Temperature Probe, Disposable, 400 Series

Model Number: M1024229

ARTG Number: 141057
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/08/2013
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue GE’s Disposable General Purpose 9FR Temperature Probe is intended for oesophageal and rectal use only. It has been brought to the attention of GE Healthcare that some users are inserting the probe nasally which may result in epistaxis (nose bleed).
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is providing users with an update to the Instructions for Use (IFU) and pouch label to clarify insertion locations.
Contact Information 1800 659 465 - GE Healthcare National Call Centre