China NMPA Product Recall - Disposable vacuum blood collection tubes

Becton, Dickinson and Company, through its agent Becton Medical Devices (Shanghai) Co., Ltd., initiated a voluntary Class II recall of certain single-use vacuum blood collection tubes. The recall was reported to the National Medical Products Administration (NMPA) on April 1, 2018, and publicly announced on May 9, 2018. The primary issue identified was that approximately 3.4% of specific tube batches, particularly those with sodium citrate additive and a 2.7ml aspiration volume, exhibited an aspiration volume exceeding the standard by 1-4%. This defect could potentially impact the accuracy of clinical blood sample testing. The affected product models include 363083, 364305, and 366560, identified by registration certificate code 20152663811. While the recall impacts countries such as the USA, Japan, UK, and Brazil, no corrective actions or handling measures were required within China. The manufacturer confirmed that the specific batches of affected products were not imported into the Chinese market, thus posing no risk to local patients or healthcare providers under the NMPA's regulatory oversight. This proactive measure by Becton, Dickinson and Company demonstrates their commitment to product quality and patient safety globally.