China NMPA Product Recall - Medical surgical masks

Henan Huayu Medical Device Co., Ltd. initiated a voluntary Level III recall for two batches of its medical surgical masks, as reported to the National Medical Products Administration (NMPA) on August 28, 2020, with internal reports dated August 26, 2020. The recall stemmed from the products' non-compliance with regulatory standards for medical devices in China.

The primary issues for the first batch (Model: Flat Type, Batch: 200102) included substandard filtration efficiency and inadequate tensile strength of the mask straps. The second batch (Model: Flat Type, Production Batch Number: 200206) failed both bacterial filtration efficiency (BFE) and tensile strength tests. These quality deficiencies compromised the masks' intended purpose of providing a physical barrier for clinical medical personnel during invasive procedures.

In response, Henan Huayu Medical Device Co., Ltd. promptly issued recall letters to affected sales and user units, including Beijing Yinuo Chuxin Jia'an Pharmaceutical Co., Ltd. Investigations confirmed that all affected products from both batches had already been utilized, resulting in a recall quantity of zero for each. Importantly, no adverse reactions or adverse events were observed or reported during the clinical use of these masks. The company also conducted inspections of its finished goods warehouse to prevent further distribution of non-compliant products, aligning with NMPA's medical device recall regulations.