China NMPA Product Recall - Disposable percutaneous drainage cannula

Baguang Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its disposable percutaneous drainage cannulas (PTCD) on June 29, 2020. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, stemmed from identified inconsistencies between the product's Chinese instructions for use and its NMPA registration certificate (National Medical Device Registration No. 20153151697).

The main issues involved two critical discrepancies. Firstly, the instructions for use indicated an indwelling time of "> 24h~30 days" and characterized it as "long-term indwelling." In contrast, the 2015 product registration certificate only specified ">24h~30 days" without the