Intersurgical has issued a Field Safety Notice (FSN) in relation to Various Clear-Therm™ Mini HMEF devices.
A potential problem has been identified with various Intersurgical Clear-Therm Mini HMEF products where the two housings of some devices have been found to separate when a force is applied during handling, or movement and torsion due to repositioning of the patient.
NVS only stock one of the products affected detailed below. Please read the attached FSN from Intersurgical and follow the detailed steps within. This is NOT a recall
Transmission of this Field Safety Notice.
This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.
What to do next:
Please examine your stock immediately & if you have any of the affected BATCH.
- Perform the test detailed within the Intersurgical FSN.
- If the fault is detected quarantine the product
- Contact our Customer Services Team on 01782 771111 (Option 3) to arrange the return of the products.
Please read the attached notification letter from the Intersurgical for more detail (Click here)
Please note:
This is not a product recall due to the current limited availability and to allow continuity of supply of the Clear-Therm™ Mini HMEF devices.