| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00535-1 |
| Product Name/Description |
Corpuls3 CO2 Disposable Naso-oral Adaptor Capone
Product Code: CP-4234.21
All Lot Numbers
ARTG Numbers: 281369 and 192745 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. The mouth piece is manufactured to be manually removed if clinically necessary. The results of an investigation revealed that it occurred due to a high level of patient agitation. There is a potential risk of asphyxiation if this problem occurs. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated.
Users are also requested to retain a copy of their recall letter with the IFU of the affected device.
This action was closed out on the 24/09/2018. |
| Contact Information |
02 9972 8353 - Device Technologies |