China NMPA Product Recall - Implantable intravenous drug delivery system

Smiths Medical ASD, Inc. initiated a voluntary Class III recall of its implantable intravenous drug delivery systems, specifically PORT-A-CATH® trays with GRIPPER® needles. This recall, reported by Smiths Medical Devices (Beijing) Co., Ltd. to the National Medical Products Administration (NMPA) on July 8, 2019, addresses a critical issue: certain GRIPPER® needles manufactured between June 11, 2018, and February 21, 2019, may be blocked or clogged. While no deaths or serious injuries have been reported, this defect could significantly delay medical treatment as affected products would require immediate replacement during procedures. The recall impacts 79,764 units sold in China and has a global reach. Under the NMPA's regulatory requirements, Smiths Medical must issue emergency recall notices to distributors, instructing them to inform customers and facilitate the return of all affected product batches. Subsequently, all recalled implantable intravenous drug delivery systems are to be returned to Smiths Medical Devices (Beijing) Co., Ltd. for proper disposal, ensuring their complete removal from circulation and safeguarding patient care.