CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Summary
The FDA issued a Class II for CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE by Kung Shin Plastics Co. Ltd.. Reason: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfuncti.
Details
Source
Device Recall
External ID
Z-1269-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Lot/Code Info: UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
Quantity Affected: 30000 ea/ 300 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.
Distribution
US Nationwide distribution in the state of IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-09
Company
Taipei Hsien
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Kung Shin Plastics Co. Ltd. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kung Shin Plastics Co. Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kung Shin Plastics Co. Ltd. have FDA actions?
Kung Shin Plastics Co. Ltd. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1269-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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