| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00941-1 |
| Product Name/Description |
AMSORB PLUS PREFILLED G-CAN 1.0L (GE part# 2105489-003)
Lot number 110122F312
ARTG 311181
(GE Healthcare Australia Pty Ltd - Anaesthesia absorber cartridge) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/07/2022 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare is notifying that a small number of AMSORB devices are associated with gas leakage originating from an interface within the G-CAN, where the purple-coloured lid interfaces with the canister body. Each device is expected to be subjected to a pre-use test before clinical use. A canister exhibiting gas leakage, beyond levels tolerated by the controlling firmware on the connected device (models Aisys, Avance and Aespire series) will be identified during pre-use test of the anaesthesia workstation prior to clinical use.
Possible non-function of device could lead to a delay in treatment.
No adverse events have been reported associated to the issue to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
GE will replace all impacted devices.
Customers are to:
1.In the event customers have opted to temporarily retain their stock, they must conduct the pre-use test and do not use any canister that fails the test
2.Where unexpected loss of gas volume from the breathing circuit in clinical use is observed, with or without associated anaesthesia machine alarms - the canister should be replaced intraoperatively.
3.Where such a replacement canister is then subject to loss of gas volume from the breathing system, the fresh gas flow rate should be temporarily increased sufficiently to overcome the gas loss and the canister replaced as soon as practicable thereafter
4.Where an installed canister no longer adequately absorbs CO2 during an anaesthesia procedure, the fresh gas flow rate should be increased above the required minute ventilation volume for the period until a new canister can be connected to the anaesthesia workstation.
This action has been reviewed and closed out. |
| Contact Information |
1800 659 465 - Customer services - GE Healthcare |