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 |
|
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 |