Kung Shin Plastics Co. Ltd. has recalled 80,000 CircuitGuard filters, including ThermoFlo and Bacterial/Viral models, because plastic may block the connector and prevent airflow. This defect can cause ventilation bags to malfunction, making it impossible to properly inflate or deflate the bag during manual breathing support. While no injuries have been reported, the blockage poses a severe risk to patients who rely on these devices for oxygen. Consumers and healthcare providers should stop using the affected filters and contact the manufacturer or their distributor to arrange for a replacement or return.
A piece of plastic may block the filter's connector, which completely obstructs airflow between the patient and the ventilation system. This can lead to sudden oxygen deprivation and respiratory distress during medical procedures.
Clinical/Hospital Device Correction
50,000 units affected; 500 cases total.
30,000 units affected; 300 cases total.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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