CircuitGuard Bacterial/Viral Filter with Elbow… recallZ-1269-2025 · Kung Shin Plastics Co. Ltd. · initiated Jan 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kung Shin Plastics Co. Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1269-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2025
- Posted by the FDA
- Mar 4, 2025
- Recalling firm
- Kung Shin Plastics Co. Ltd.
- Quantity
- 30000 ea/ 300 cases
- Product code
- CAH
- FDA submissions
- K032878
- Distribution
- US Nationwide distribution in the state of IL.
Product description
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Code information (models, lots, serial numbers)
UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- circuitGuard® FilterFlo™ 7056Typenex Medical LLC · Filter, Bacterial, Breathing-Circuit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96224).
- Z-1268-2025 · Open, ClassifiedCircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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