China NMPA Product Recall - Disposable maternity pack

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Nanchang Kang Sheng Medical Device Co., Ltd., publicized on January 10, 2020. The recall pertains to the company's disposable delivery kits, identified by Registration Certificate No. Ganxiezhuzhun 20162640177. The primary reason for this action is that the ethylene oxide residue levels in these kits failed to meet established standard requirements, indicating a critical non-conformance in their sterilization process. As part of its regulatory obligations and commitment to product safety, Nanchang Kang Sheng Medical Device Co., Ltd. is undertaking the necessary steps to remove the affected products from distribution. This recall highlights the stringent quality control necessary for medical devices, particularly regarding sterilization, to ensure patient safety under the regulatory framework overseen by the NMPA. Further specifics on the product specifications and involved batches are available in the official Medical Device Recall Event Report Form.