China NMPA Product Recall - Medical magnetic heat patch

Anhui Huike Biotechnology Co., Ltd. initiated a voluntary Class III recall of its medical magnetic heating patches (Registration No.: 20152260170). The decision, published by the National Medical Products Administration (NMPA) on September 29, 2019, stemmed from findings during internal risk monitoring. On September 25, 2019, the company reported a critical product performance issue: the heating time for the medical magnetic heating patches exceeded the specified 10-minute duration. This deviation from product specifications triggered the recall to ensure patient safety and product efficacy. The NMPA oversees the regulatory framework for medical devices in China, ensuring that products meet established safety and performance standards. Anhui Huike Biotechnology Co., Ltd.'s proactive measure to recall the affected batches demonstrates adherence to these regulatory expectations. The "Medical Device Recall Event Report Form" contains specific details regarding the models, specifications, and batch numbers implicated in this recall. This action underscores the company's commitment to product quality and patient safety within the medical device industry.