CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd. · 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 whi…
Open FDA's page for this record- Cfres ID
- 212373
- Product res number
- Z-1269-2025
- Event date initiated
- 2025-01-09
- Event date posted
- 2025-03-04
- Recall status
- Open, Classified
- Res event number
- 96224
- Product code
- CAH
- Product description
- CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
- Code info
- UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
- Firm FEI number
- 3004116032
- Recalling firm
- Kung Shin Plastics Co. Ltd.
- Address 1
- 65-2 Erh Chia Road
- City
- Taipei Hsien
- State
- Ying Kuo Town
- Country
- Taiwan
- Additional info contact
- Mr. Chien Chih Yang 886 3 5208829
- Root cause description
- Process design
- Product quantity
- 30000 ea/ 300 cases
- Distribution pattern
- US Nationwide distribution in the state of IL.
- 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.
- 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.
- K numbers
- K032878
- Harmonized identifiers (openFDA)
- Device name
- Filter, Bacterial, Breathing-Circuit
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5260
- Device class
- 2
- K number
- K840205, K812098, K970102, K896116, K000654, K862786, K973238, K973314, K760081, K941381, K904830, K063526, K010040, K090738, K133666, K802914, K772047, K844492, K944124, K791307, K862787, K925388, K002201, K101629, K934509, K024270, K781696, K030271, K982127, K980662, K941536, K964382, K833066, K903056, K920885, K093426, K801803, K990949, K841236, K043148 +162 more
- Registration number
- 3003399703, 3012329712, 3033959233, 3030446844, 3000268902, 3018094310, 3011503227, 3004122598, 9680661, 3006254047, 8043316, 3020614, 3005519819, 3014421917, 3006673317, 2518443, 8040412, 1220253, 1055236, 9616567, 3005855942, 1314417, 3015168843, 9611500, 8021995, 3017520736, 3011137372, 3010877292, 1526863, 3006157842, 3010402691, 3004874794, 3001124136, 9710567, 3023294726, 3031369651, 3010834934, 3007709321, 3009896423, 3011088743 +102 more
- FEI number
- 3003399703, 3012329712, 3033959233, 3030446844, 3000268902, 3018094310, 3011503227, 3004122598, 3006254047, 3020614, 3005519819, 3014421917, 3003256355, 1000283452, 2518443, 1220253, 3005855942, 1314417, 3015168843, 3017520736, 3010877292, 1526863, 3006157842, 3010402691, 3002673652, 3004874794, 3001124136, 3023294726, 3031369651, 3010834934, 3007709321, 3009896423, 3011088743, 1024404, 3008311916, 3005515211, 3010131137, 2025816, 3006534321, 3027977504 +102 more