China NMPA Product Recall - Disposable sterile vaginal speculum

Taizhou Kangjian Medical Device Co., Ltd. initiated a Class III voluntary recall of its disposable sterile vaginal specula (Registration Certificate No.: Zhexiezhuzhun 20182660018) on January 21, 2019. This action followed national medical device supervision and spot checks conducted by the National Medical Products Administration (NMPA), which identified non-compliance in the structural strength of two product batches, specifically 20180205 and 20180414. The inspections, carried out by the Jiangsu Provincial Food and Drug Administration on behalf of the NMPA, revealed that these batches failed to meet the required structural integrity standards. The recall impacts approximately 26,400 units sold in China from the affected batches, with 14,400 units from batch 20180205 and 12,000 units from batch 20180414 already distributed. As part of the required actions, Taizhou Kangjian Medical Device Co., Ltd. is recalling these products. The company reported that 5,600 units from batch 20180205 and 8,000 units from batch 20180414 remained in stock and would be properly disposed of in collaboration with drug regulatory authorities. This recall underscores the importance of stringent quality control within the medical device industry to ensure patient safety and product efficacy.