| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00366-1 |
| Product Name/Description |
D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
(used in Anaesthesia and Critical Care areas)
D-Fend
Product number: 876446-HEL: Lot Numbers: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108
D-Fend+
Product number: 881319-HEL : Lot Numbers:: J9906966, J9965152, J10258251, J10300071
ARTG Number: 208210 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Occlusion of specific lots of D-Fend/D-Fend+ water traps could occur immediately after replacement. This water trap occlusion could cause a loss of respiratory airway gas monitoring. When this issue is detected the connected monitoring device will issue an audio alarm and display “low gas sample flow”, “replace water trap” or “sampling line blocked” warning messages. Unattended or prolonged warnings could lead to an adverse clinical situation if the CO2 value would rapidly change in certain clinical conditions.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to collect and dispose of the affected water traps. GE Healthcare will replace all affected products. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |