| 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 |
|
| 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 |