FDAFDA · Food and drugs·Recall number Z-1269-2025
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Published March 12, 2025 · Recall initiated: January 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Kung Shin Plastics Co. Ltd.
- Distributor
- US Nationwide distribution in the state of IL.
- Lot
- UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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