China NMPA Product Recall - Vena cavum filter and its guiding system

B. Braun Medical France, through its agent B. Braun Medical (Shanghai) International Trading Co., Ltd., initiated a voluntary Class II recall of its Inferior Vena Cava Filters and Guidance Systems (Product No. 20143136131). The recall was reported on November 6, 2019, and publicly announced by the National Medical Products Administration (NMPA) on November 18, 2019. The core issue stemmed from a packaging mix-up involving product model 04435125, batch number 36939121. User complaints revealed that the packaging for a standard vena cava filter inadvertently contained a "convertible vena cava filter," leading to potential patient risks. This device is designed for implantation into the inferior vena cava to prevent pulmonary embolism by intercepting thrombi. Under the NMPA's regulatory oversight, the manufacturer proactively recalled the affected product. While the recall encompasses the identified single affected product, no further action is required within China, as zero units of the specific affected batch were sold or distributed in the country. The company fulfilled its regulatory obligation by reporting the incident to the appropriate authorities.