CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
This recall is currently active, issued March 4, 2025. It was issued by Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan.
- Recall Initiated
- January 9, 2025
- Posted
- March 4, 2025
- Recall Number
- Z-1268-2025
- Quantity
- 50000 ea/ 500 cases
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of IL.
Lot / Code Info
UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
Root Cause
Process design
Action Taken
On January 9, 2025, the firm sent a recall notice to their sole distributor in the US, followed by a more detailed notice on January 10. Customers were instructed to locate and immediately discontinue use of affected products. Affected product should be quarantined and returned. If products of affected batches have been sold, the distributor should immediately notify the buyers to stop using them, quarantine them, and destroy them.