China NMPA Product Recall - Natural latex rubber condoms

Heze Kangshen Pharmaceutical Co., Ltd. initiated a voluntary Class III recall for its natural latex condoms (Batch No. 20180318). The company reported to the National Medical Products Administration (NMPA) that a malfunction in its electrical testing machine caused this specific batch to fail essential product technical requirements, specifically concerning burst pressure and burst volume.

The recall impacts 671 boxes of condoms sold in China, identified under Registration Certificate No. Lu Xie Zhu Zhun 20172660815. The issue was officially reported on September 24, 2018, leading to the NMPA's publication of the recall on December 29, 2018.

As part of the required actions, Heze Kangshen Pharmaceutical Co., Ltd. notified all relevant distributors to retrieve the non-compliant products. A recall notice was issued to facilitate the replacement of the affected condoms. This proactive measure ensures consumer safety by addressing products that do not meet established quality and performance standards.