China NMPA Product Recall - Natural latex rubber condoms

On January 29, 2021, Toyo Matsushita Latex (Jinzhou) Co., Ltd. initiated a voluntary Class III recall for specific batches of its natural latex condoms. This recall was prompted by critical quality control findings, specifically that the condoms failed to meet the required burst volume and pressure standards prior to aging. These non-conformities are in direct violation of the stringent GB7544-2009 standard, a key component of the regulatory framework governing such medical devices in China. The National Medical Products Administration (NMPA) publicized this recall, stemming from the company's own report to the Liaoning Provincial Drug Administration. The affected products carry the registration number Liaoning Medical Device Registration No. 20172660192. As a required action, Toyo Matsushita Latex (Jinzhou) Co., Ltd. is actively withdrawing these products from the market. Stakeholders, including healthcare providers and consumers, are advised to refer to the 'Medical Device Recall Event Report Form' for comprehensive information regarding the precise models, specifications, and batch numbers impacted by this recall. This measure underscores the commitment to public safety and adherence to national quality and performance benchmarks for medical products.