China NMPA Product Recall - Disposable masks

The National Medical Products Administration (NMPA) of China announced on December 10, 2018, that Nanchang Huayi Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable masks. This action was taken because the product failed to meet standard requirements for ethylene oxide residue, indicating a critical quality control issue related to the sterilization process. The affected disposable masks are identified by registration number 20172640274.

The NMPA, as the primary regulatory authority for medical products in China, published this recall notice to ensure public awareness and safety. While specific inspection dates were not detailed in the recall document, the voluntary action underscores non-compliance with essential product safety standards. As a required action, Nanchang Huayi Medical Device Co., Ltd. is responsible for providing comprehensive information regarding the specific models, specifications, and batches of the recalled products through a formal Medical Device Recall Event Report Form. This recall highlights the ongoing regulatory oversight by the NMPA to maintain product integrity and protect public health from potentially violative medical devices.