FDA Medical devices recall ·
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger… recall
- Recall number
- Z-1268-2025
- Date
- (initiated January 9, 2025)
- Company / brand
- Kung Shin Plastics Co. Ltd.
65-2 Erh Chia Road, Taipei Hsien, Taiwan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50000 ea/ 500 cases
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
Distribution
US Nationwide distribution in the state of IL.
States: Illinois
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1268-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.