China NMPA Product Recall - Xiaoyelang Natural Latex Rubber Condoms

Jining Weikang Adhesive Industry Co., Ltd., also identified as Jining Weikang Rubber Industry Co., Ltd., initiated a voluntary Class III recall on December 28, 2018, for its Natural Latex Rubber Condoms (Xiaoyelang brand, Batch 170902). These condoms, produced in September 2017, were found to be non-compliant with critical quality standards during a random inspection conducted by the Hangzhou Medical Device Quality Supervision and Inspection Center, under the regulatory framework of the National Medical Products Administration (NMPA) in China. The main violations identified were failures in both "burst volume and pressure" and "pinhole" tests. These defects are crucial as they compromise the product's integrity and intended function for contraception and prevention of sexually transmitted diseases. In response, Jining Weikang implemented several required actions. Customers who purchased products from the affected batch (170902) were formally instructed to cease use. All remaining units of this batch on the market were to be recalled and subsequently destroyed. Furthermore, the company committed to strengthening its workshop production and quality management training to prevent similar issues from recurring. The recall specifically affected Wuwei City, Gansu Province, involving 7168 units sold in China.