China NMPA Product Recall - Injection suction pump

Richard Wolf GmbH initiated a voluntary Class III recall of specific infusion and suction pump tubing sets in China, as reported to the National Medical Products Administration (NMPA) on October 23, 2019, with publication on November 4, 2019. The recall stems from a programming error in tubing sets, specifically batch number 4015874 (model 8171223), which were designed for 20 reuses but could potentially be used up to 255 times. A critical issue identified was that some accompanying suction pumps lack a display function, preventing users from monitoring the tubing set's actual usage count. This flaw could lead to extended use beyond the intended lifespan, posing a potential safety risk during arthroscopic diagnosis and surgery, for which the product is intended. Operating under the NMPA's medical device regulatory framework, Richard Wolf GmbH, via its agent Beijing Dehua Xinda Technology Co., Ltd., is undertaking several corrective actions. These include distributing emergency safety information to Chinese distributors, requiring them to compile product sales data, and arranging for the centralized destruction of all 17 affected units sold in China. This proactive measure aims to mitigate risks associated with the unintended overuse of medical device components.