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U.S. Department of Health and Human Services

Class 2 Device Recall CircuitGuard

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 Class 2 Device Recall CircuitGuardsee related information
Date Initiated by FirmJanuary 09, 2025
Date PostedMarch 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1269-2025
Recall Event ID 96224
510(K)NumberK032878 
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
ProductCircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Code Information UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
FEI Number 3004116032
Recalling Firm/
Manufacturer		 Kung Shin Plastics Co. Ltd.
65-2 Erh Chia Road
Ying Kuo Town
Taipei Hsien Taiwan
For Additional Information ContactMr. Chien Chih Yang
886 3 5208829
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionOn 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.
Quantity in Commerce30000 ea/ 300 cases
DistributionUS Nationwide distribution in the state of IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CAH
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