Kung Shin Plastics recalls CircuitGuard Bacterial/Viral Filters with Elbow (Model SK200FPE) due to potential ventilation bag malfunction causing oxygen deprivation. Affected units have specific UDI codes.
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.
Kung Shin Plastics is recalling CircuitGuard Bacterial/Viral Filters with Elbow (Model SK200FPE) because a plastic blockage in the machine side connector may prevent proper airflow. This could cause the ventilation bag to malfunction during manual ventilation, risking oxygen deprivation and respiratory distress.
The machine side connector may become blocked by plastic, preventing proper airflow. This can cause the ventilation bag to malfunction during manual ventilation, leading to oxygen deprivation and potential respiratory distress.
Healthcare professionals using the CircuitGuard filter for manual ventilation are most at risk. Patients receiving manual ventilation with this model may experience oxygen deprivation if the filter malfunctions.
Check for the model number SK200FPE on the filter. Affected units have a specific UDI code: (01)00810050853682(10)C2N24002(11)240828(17)290827.
Look for the model number SK200FPE on the filter's label.
Reach out to Kung Shin Plastics for specific guidance on next steps.
The machine side connector may become blocked by plastic, preventing proper airflow and causing ventilation bag malfunction during manual ventilation.
Potential risks include oxygen deprivation, leading to respiratory distress and medical complications.
Check for the model number SK200FPE and the UDI code (01)00810050853682(10)C2N24002(11)240828(17)290827 on the filter.
We’ve drafted a message you can send Kung Shin Plastics to request your refund or repair — edit it as you like.
Subject: Recall Z-1269-2025 — Kung Shin Plastics Kung Shin Plastics Hello, I own a Kung Shin Plastics that is covered by recall Z-1269-2025 from Kung Shin Plastics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
