CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Recall
- Recall Number
- Z-1268-2025
- Event Number
- 96224
- Firm
- Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan
- FEI Number
- 3004116032
- Product Code
- CAH
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- January 9, 2025
- Posted
- March 4, 2025
Description
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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.
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.
US Nationwide distribution in the state of IL.
50000 ea/ 500 cases