China NMPA Product Recall - Tracheostomy tube

Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, through its Singapore Tyco Medical Devices Co., Ltd. Beijing Representative Office, issued a voluntary recall report to the National Medical Products Administration (NMPA) on June 18, 2010. The report concerned Shiley

Tracheostomy Tubes (NMPA Imported Medical Device Registration No. 20072661153), a product vital for pediatric patients requiring assisted ventilation across a wide global distribution, including China. The primary issue identified was a defect in the balloon inflation device, causing the tracheostomy tube's airbag to leak and fail to retain air. This malfunction posed a significant health risk, potentially leading to compromised ventilation, sudden drops in blood oxygen, or increases in carbon dioxide, particularly critical for patients on mechanical ventilation. The affected products were manufactured between November 1, 2008, and September 25, 2009. In response, the company initiated a comprehensive corrective action plan. This began in July 2009 with enhanced quality alert procedures and continuous batch inspections. By August 2009, leak testers were installed to detect malfunctions, and all affected airbag inflators were removed. The supplier for the faulty inflators was replaced with an approved vendor. Tyco Healthcare also isolated all affected batches and ensured a sufficient supply of compliant replacement products. The recall activity in China involved a total of 1096 units across distributor and hospital inventories.