Kung Shin Plastics Co. Ltd. recalls CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
- Recall date
- January 9, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1269-2025
- FDA classification
- Class II
- Brand / firm
- Kung Shin Plastics Co. Ltd.
- Sold / distributed
- US Nationwide distribution in the state of 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Get recall alerts
Free email alert whenever Kung Shin Plastics Co. Ltd. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Kung Shin Plastics Co. Ltd.