Recall Z-1269-2025 ยท CAH Filter, Bacterial, Breathing-Circuit
Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
| Date | Mar 4, 2025 (initiated Jan 9, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032878 | KUNG SHIN, HMEF SK203 Kung Shin Plastics Co., Ltd., Sep 20, 2004 |