China NMPA Product Recall - Natural latex rubber condoms

The National Medical Products Administration (NMPA) of China issued a Level 3 medical device recall, detailed in a report published on December 17, 2018. This recall involved Natural Latex Rubber Condoms manufactured by Suretex Prophylactics (India) Limited and distributed in China by Wuhan Jissbon Hygiene Products Co., Ltd. The primary issue stemmed from product samples, specifically batch number LF170605, failing a routine medical device sampling inspection. This failure indicated a quality or safety non-conformity, prompting the regulatory action. Approximately 19,156 boxes of the affected "Non-gloss type" condoms were sold in China. A Level 3 recall, under the NMPA framework, signifies that while the product is violative, its use or exposure is not likely to cause adverse health consequences. In response, the company implemented several corrective actions: distributors were immediately instructed to halt sales of the affected batch, and all remaining products in warehouses and retail outlets were mandated for return. The recall process has been successfully completed, with all retrieved products securely sealed in the company's designated warehouse, demonstrating adherence to NMPA's safety standards.