China NMPA Product Recall - Implantable intravenous drug delivery system

Smiths Medical ASD, Inc., through its local agent Smiths Medical Devices (Beijing) Co., Ltd., initiated a voluntary Class III recall of certain implantable intravenous drug delivery systems. This recall, formally reported to the National Medical Products Administration (NMPA) on July 8, 2019, and published on July 15, 2019, addresses an issue with GRIPPER® needles manufactured between June 11, 2018, and February 21, 2019. The primary concern is that individual needles within these systems may be blocked or clogged, which would necessitate product replacement and could delay the commencement of patient treatment. Although no deaths or serious injuries have been reported globally due to this issue, the company emphasizes patient safety. The affected products, bearing National Medical Device Registration Certificate 20173661683, totaled 79,764 units sold in China. As part of the corrective action, Smiths Medical instructed distributors to issue emergency recall notices to their customers and arrange for the return of all implicated products to Smiths Medical Devices (Beijing) Co., Ltd. for proper disposal, ensuring compliance with NMPA regulations.