China NMPA Product Recall - Medical surgical masks

Henan Lantian Medical Device Co., Ltd. initiated a voluntary Level III recall of its medical surgical masks due to critical quality failures. The recall was prompted by substandard performance in pressure differential and sterility tests, indicating a potential risk to users. The affected product is identified by Production Batch Number 00218060502, specifically the flat model, and was sold by the company to Handan Central Hospital. This recall action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. Upon discovering the non-conformance, Henan Lantian Medical Device Co., Ltd. conducted an immediate inspection of its finished goods warehouse, finding that the entire problematic batch had already been distributed. Consequently, the company promptly issued a recall notice to Handan Central Hospital, the sole reported recipient of this batch. Investigations confirmed that the masks had already been used, with no remaining stock in the hospital's consumables warehouse. The recall report was signed on July 26, 2019, and published by the NMPA on October 25, 2019, underscoring the company's responsibility in addressing product safety concerns.