CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Reported: March 12, 2025 Initiated: January 9, 2025 #Z-1268-2025
Product Description
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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.
Details
- Recalling Firm
- Kung Shin Plastics Co. Ltd.
- Units Affected
- 50000 ea/ 500 cases
- Distribution
- US Nationwide distribution in the state of IL.
- Location
- Taipei Hsien
Frequently Asked Questions
What product was recalled? ▼
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126). Recalled by Kung Shin Plastics Co. Ltd.. Units affected: 50000 ea/ 500 cases.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1268-2025.
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