China NMPA Product Recall - Disposable sterile syringes

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of various disposable sterile syringes, as reported to the National Medical Products Administration (NMPA) on September 25, 2015. The recall stems from findings by the company's US headquarters, Becton Dickinson and Company, which identified that some users in the United States were utilizing the syringes outside their approved scope. Specifically, these syringes were being employed as sealed containers for pre-administration drug storage, a practice confirmed to potentially diminish drug efficacy for certain medications. The affected products, imported under registration certificate CFDA (Imported) 2014 No. 3154648, include millions of units sold in China. However, the company confirmed no related customer feedback or issues have been reported within China. As a proactive measure, BD Medical Devices (Shanghai) Co., Ltd. is issuing customer letters to communicate the proper intended use and the potential risks of off-label storage. Importantly, this recall does not necessitate product returns or replacements, and the syringes are permitted to continue being sold in China, as the issue pertains to misuse rather than a product defect affecting their primary intended use for injections.