Drug recall
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
FDA recall event 96224 · Class II · Kung Shin Plastics Co. Ltd.
Key facts
| Event ID | 96224 |
|---|---|
| Recall numbers | Z-1268-2025, Z-1269-2025 |
| Recalling firm | Kung Shin Plastics Co. Ltd. |
| Product type | Devices |
| Products | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056), CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jan 9, 2025 |
| Report date | Mar 12, 2025 |
| City | Taipei Hsien |
| Country | Taiwan |
| FEI number | 3004116032 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: