Recall Z-1268-2025— Kung Shin Plastics Co. Ltd.
Class II · Ongoing
Class II FDA medical device recall by Kung Shin Plastics Co. Ltd., initiated 2025-01-09. It names one FDA 510(k) clearance: K032878. Product: CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126). Reason: 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..
- Recalling firm
- Kung Shin Plastics Co. Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-09
- Firm location
- Taipei Hsien, Taiwan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.