| TGA Action ID |
RC-2025-RN-00925-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ErgoStars with smoothbore hoses incl. Sets and Packs using those products
ErgoStar CM 40
Part No. MP01840
ErgoStar CM 45
Part No. MP01845
ErgoStar CM 55
Part No. MP01855
ErgoStar CM 60
Part No. MP01860
CombiStar Plus Filter + HME straight
Part No. MP12060
Pack2Go Evita invasive Vpack CO2 Cuvette
Part No. MP20370
Pack2Go Evita invasive Vpack
Part No. MP20371 |
| ARTG Number |
287190, 374261, 461205 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Dräger has become aware of cases in which cracks have formed in the hose of some specific ErgoStar catheter mounts. No patient harm was reported in these events.
In case such cracks form during use, leakage will occur. Depending on the size of the leakage and the selected ventilation pressure, the ventilator / anaesthesia device can compensate for this. If the leakage cannot be compensated for, ventilation is restricted, and the patient may experience desaturation/hypoxia. Ventilators according to ISO 80601-2-12 and anaesthesia devices according to ISO 80601-2-13 will generate visual and audible alarms according to the set alarm limits. |
| Instructions for Customers/Users |
Customers should identify affected products in their inventory and cease use of the ErgoStar.
All components in the affected Pack2Go except for the ErgoStar may be used properly.
Dräger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement.
This product is not affected by the current issue and can replace stock free of charge through the Dräger representative. Please note that it is not the identical item, but a comparable alternative from Dräger's portfolio.
This action has been finalised on 17/4/2026. |
| Action Commencement Date |
30/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 372 437 - Customer service |