CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
FDA Recall Z-1268-2025 · Posted 2025-03-04
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Recalling FirmKung Shin Plastics Co. Ltd.
Recall StatusOpen, Classified
Product CodeCAH
Date Initiated2025-01-09
Product Quantity50000 ea/ 500 cases
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.
Firm Action
On January 9, 2025, the firm sent a recall notice to their sole distributor in the US, followed by a more detailed notice on January 10.
Customers were instructed to locate and immediately discontinue use of affected products. Affected product should be quarantined and returned.
If products of affected batches have been sold, the distributor should immediately notify the buyers to stop using them, quarantine them, and destroy them.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the state of IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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