FDA-Device2025-03-12Class II
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Kung Shin Plastics Co. Ltd.
Hazard
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.
Sold states
US Nationwide distribution in the state of IL.
Affected count
50000 ea/ 500 cases
Manufactured in
65-2 Erh Chia Road, Ying Kuo Town, Taipei Hsien, Taiwan
Products
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2025Don't want to check this manually?
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