China NMPA Product Recall - Disposable laparoscopic trocar

Tonglu Kang'er Medical Device Co., Ltd. initiated a voluntary Level 3 recall on January 17, 2019, for its disposable laparoscopic puncture devices (Registration Certificate No.: Zhexiezhuzhun 20172220504). This action stemmed from a national medical device supervision and spot check, overseen by the National Medical Products Administration (NMPA), which identified a significant quality deviation. The primary issue was that the maximum mating clearance between the puncture cannula and puncture needle exceeded the standard requirement of 0.3mm.

The recall applied to product model Ф5.5, specifically batch number C01D180206, consisting of 250 sets. The company reported that no units from this affected batch were sold in China. The remaining 206 sets, after allocations for sampling and internal use, were subsequently seized by the Tonglu County Market Supervision and Administration Bureau, effectively preventing market distribution and negating a broader public recall.

As part of its corrective actions, Tonglu Kang'er Medical Device Co., Ltd. adjusted all production molds to align with the testing methods prescribed by the Shanghai Inspection Institute, confirming that all new samples now meet the required specifications. The company has also committed to strengthening its internal quality management, enhancing employee understanding of relevant standards, and improving professional technical skills to ensure future product compliance under the NMPA's regulatory framework.