CircuitGuard ThermoFlo Filter -Combined Heat and recall
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE /…
Why was CircuitGuard ThermoFlo Filter -Combined Heat and recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
- Product
- CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE /…
- Recalling firm
- Kung Shin Plastics Co. Ltd.
- Quantity
- 50000 ea/ 500 cases
- Distribution
- US Nationwide distribution in the state of IL.
- Recall date
- March 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)