Device product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Z-1268-2025
Product summary
- Event
- Event 96224
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50000 ea/ 500 cases
- Official record key
device-enforcement:Z-1268-2025
Official wording
Reason: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Code information: UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
Distribution pattern: US Nationwide distribution in the state of IL.
Derived failure modes
-
Unknown
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.