China NMPA Product Recall - Medical cotton swabs and disposable sterile dressing packs

Henan Asia-Pacific Medical Supplies Co., Ltd. initiated a voluntary Level III recall for specific medical products, as announced on December 22, 2020. This action, overseen by the National Medical Products Administration (NMPA) through the Henan Provincial Drug Administration, addresses significant quality control deficiencies. The recall involves two distinct product types: medical cotton swabs and disposable sterile dressing kits. For one batch of medical cotton swabs, the primary issue identified was non-compliance with established regulations concerning the weight of their cotton heads. Separately, a batch of disposable sterile dressing kits was found to contain non-compliant levels of ethylene oxide residue. These violations prompted the company to undertake a Level III recall, indicating that while the issues are significant, the likelihood of severe adverse health consequences from product use or exposure is considered low. The required action for Henan Asia-Pacific Medical Supplies Co., Ltd. is to ensure the complete removal of these non-compliant products from the market. This voluntary recall underscores the critical importance of rigorous adherence to quality and safety standards in medical device manufacturing to protect public health. Detailed information on affected models, specifications, and batch numbers is available in the company hands Medical Device Recall Event Report Form.