China NMPA Product Recall - Disposable ordinary medical mask

Hunan Zhenhe Yikang Medical Supplies Co., Ltd. has initiated a voluntary Level III recall of its disposable ordinary medical masks, as reported to the Hunan Provincial Drug Administration on December 20, 2019, and publicly announced by the National Medical Products Administration (NMPA) on December 25, 2019. The recall specifically targets product batches 20190625 and 20190706. These masks were found to be non-compliant with their registered product technical requirements, with a critical issue identified in the fragmentation strength, which failed to meet established standards. This deficiency impacts the masks' intended use for blocking contaminants in ordinary medical environments. The recall affects 2250 packs from batch 20190625 and 40 packs sold from batch 20190706.

Under the NMPA's regulatory framework, Hunan Zhenhe Yikang Medical Supplies Co., Ltd. is required to issue comprehensive recall notices to all domestic customers and obtain confirmation of receipt. All affected products must be returned to the manufacturer for appropriate handling and processing. Additionally, the company is mandated to conduct an internal audit to thoroughly investigate and pinpoint the underlying causes of the non-compliance, thereby ensuring corrective and preventive actions are implemented to uphold product quality and patient safety.