Medical Device Recall: CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd. · January 9, 2025
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.
Distribution
US Nationwide distribution in the state of IL.
States Affected
NATIONWIDE
Quantity Affected
30000 ea/ 300 cases
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1269-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.