Z-1268-2025 Class II Ongoing
FDA device recall Z-1268-2025 was initiated by Kung Shin Plastics Co. Ltd. on January 9, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 50000 ea/ 500 cases.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- January 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50000 ea/ 500 cases
Product Description
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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 properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Distribution Pattern
US Nationwide distribution in the state of IL.
Code Information
UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002