China NMPA Product Recall - Natural latex rubber condoms

The National Medical Products Administration (NMPA) published a Level III medical device recall event report on December 14, 2018, concerning Natural Latex Rubber Condoms. The recall was initiated by Suretex Prophylactics (India) Wuhan Jissbon Hygiene Products Co., Ltd. The primary reason for the recall was the failure of product samples during a routine medical device sampling inspection. Specifically, the affected products were 'Non-smooth type' condoms from batch LF170605, with 19,156 boxes sold in China requiring recall. As part of the regulatory requirements, the company took immediate action to address the non-compliance. Distributors of the affected batch were notified to cease sales through all channels and instructed to return all inventory from their warehouses and retail outlets. The report indicates that the recall process has been completed, with all returned products sealed within the company's warehouse. This action ensures consumer safety by removing substandard products from the market in accordance with NMPA's regulatory framework.