Class II — Kung Shin Plastics Co. Ltd.
| Recalling firm | Kung Shin Plastics Co., Ltd. |
|---|---|
| Registered facility | KUNG SHIN PLASTICS CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) |
| Quantity | 50000 ea/ 500 cases |
| Distribution | US Nationwide distribution in the state of IL. |
| Initiated | 2025-01-09 |
| Classified | 2025-03-04 |
| Recall number | Z-1268-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kung Shin Plastics Co. Ltd. (Z-1268-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96224/
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