Kung Shin Plastics Co. Ltd. recalls CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger

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.

• FDA enforcement recordOfficial FDA database entry for Z-1268-2025
• FDA 510(k) clearance · K032878The device's official FDA premarket clearance record
• FDA device classification · CAHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5260The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Kung Shin Plastics Co. Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.