China NMPA Product Recall - Vacuum blood collection tubes

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its vacuum blood collection tubes (Imported Medical Device Registration Number: 20152410400) following the discovery of visible foreign objects within the product. This critical quality issue, which impairs the normal use of the devices, was reported to the National Medical Products Administration (NMPA) with a publication date of July 3, 2017. The primary manufacturer for these products is Becton Dickinson and Company. The recall impacts approximately one million affected tubes, specifically from batch number 5166824 and item number 367957, with 943,000 units distributed in the Chinese market. The issue was identified internally, leading to a recall report. As a required action, BD Medical Devices (Shanghai) Co., Ltd. committed to proactively inform all affected customers about the incident through written communication, ensuring awareness and adherence to NMPA's regulatory framework for medical device safety and quality.