| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01161-1 |
| Product Name/Description |
A3/A5 Anesthesia Delivery System
ARTG:158607 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket. Should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked, and locked again to reseat the gasket. If the CO2 absorbent gasket is improperly seated, however a potential leak will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.
This recall action was not notified to the TGA before it was initiated by Ulco Medical. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ulco Medical is providing work around instructions and will be replacing the canister gasket to permanently correct the issue. |
| Contact Information |
02 9519 5881 - Ulco Medical |