Heat Moisture Exchanger Connector Occlusion May Impair Ventilation
Kung Shin Plastics' CircuitGuard ThermoFlo Filter may have plastic obstructing the machine-side connector, preventing proper ventilation bag operation and risking oxygen deprivation during manual ventilation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where no illnesses or injuries have been reported. The potential hazard—oxygen deprivation and respiratory distress—is serious, but remains theoretical. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
The CircuitGuard ThermoFlo Filter (Model SK200CPE/6126) manufactured by Kung Shin Plastics Co. Ltd. is being recalled due to potential plastic occlusion of the machine-side connector. This defect may prevent proper airflow through the filter.
If the connector is obstructed, users may be unable to properly inflate and deflate the ventilation bag during manual ventilation. This could lead to oxygen deprivation, respiratory distress, and other medical complications for patients relying on this equipment.
The recalled units were distributed in the United States and can be identified by Lot C2O24002. Users of this equipment should immediately discontinue use and contact Kung Shin Plastics or the FDA for instructions on replacement or return.
The recalled product
- Product
- CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
- Manufacturer
- Kung Shin Plastics Co. Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
Distribution
Part of a larger recall action
This product is one of 2 recalled by Kung Shin Plastics Co. Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Kung Shin Plastics Co. Ltd.
See all →- HighCircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction
FDA (Devices) · 2025-03-12
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