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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00818-3
Product Name/Description Vital Signs Disposable General Purpose 9 French Temperature probes

Product Numbers: 1016 and 1016EU
Multiple Lot Numbers
ARTG: 169063
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/08/2012
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue The use of the Disposable General Purpose 9 French Temperature Probe for nasopharyngeal applications can create, in certain clinical conditions, a potential for severe epistaxis, which may require interventional procedures or prescription medications to properly resolve. These clinical conditions include patients treated with anticoagulants or are at risk for coagulopathy.
Recall Action Recall
Recall Action Instructions GE Healthcare is recalling all probes and will be replacing them (or providing credit) with new sterile units solely to be used for oesophageal or rectal use and are updating the Instructions for Use (IFU).
Contact Information 1300 722 229 - GE National Service and Support Centre