China NMPA Product Recall - BD Vistec™ High Viscosity Injector

On February 22, 2011, the National Medical Products Administration (NMPA) issued notice regarding a recall initiated by Beaver-Visitec International, formerly Becton Dickinson and Company, Ophthalmic Systems. The recall, detailed in a manufacturer's report dated December 14, 2010, targets specific models of their BD Vistec™ high viscosity injectors. The core issue, identified by RJR Consulting, is a critical malfunction causing reduced or complete absence of flow rate from the affected devices. This market safety corrective action is managed under the Medical Device Vigilance System (MEDDEV 2.12/1 Revision 5), involving regulatory oversight from the NMPA in China and the Medicine and Healthcare Products Regulatory Agency (MHRA) in the UK, which provided a reference number for the action. Required actions include addressing the product's deficiencies through market safety measures. Provincial, autonomous region, and municipal food and drug administrations in China are closely monitoring the recall process to ensure effective implementation and protect public health. Beaver-Visitec International, with its main contact in Waltham, MA, USA, and an authorized representative in Bidford, UK, is responsible for this corrective action.