FDA Medical Device Recalls (openFDA)
Kung Shin Plastics Co. Ltd.: CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
- Recall number
- Z-1269-2025
- Recalling firm
- Kung Shin Plastics Co. Ltd.
- Product
- CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
- Status
- Open, Classified
- Initiated
- 2025-01-09
- Posted
- 2025-03-04
- Terminated
- not on file
- 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 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.
- Root cause
- Process design
- 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.
- Quantity
- 30000 ea/ 300 cases
- Distribution
- US Nationwide distribution in the state of IL.
- Lot, serial or model codes
- UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
- 510(k) numbers
- ["K032878"]
- PMA numbers
- not on file
- Product code
- CAH
- Firm FEI
- 3004116032
- Firm city
- Taipei Hsien
- Firm state
- Ying Kuo Town
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28