Reported Mar 12, 2025 · Ongoing
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kung Shin Plastics Co. Ltd. · 65-2 Erh Chia Road · Taipei Hsien · N/A
Is this the product you have?
- CircuitGuard Bacterial/Viral Filter
- with Elbow (Model/Catalogue numberSK200FPE / 7056)
- Lot codes and dates
- UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
- Amount recalled
- 30000 ea/ 300 cases
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- IL
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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