China NMPA Product Recall - Single-use sterile injection needles; single-use sterile syringes with needles

BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton Dickinson and Company, initiated a voluntary Level 3 recall, as published by the National Medical Products Administration (NMPA) on March 1, 2017, under Index No. JGXX-2017-10178. This recall pertains to specific models of disposable sterile injection needles and disposable sterile syringes with needles, including those featuring the Eclipse™ protective shield.

The core issue prompting the recall was the potential for the protective shield to detach or not fully engage, causing the needle to remain exposed and elevating the risk of accidental needlestick injuries. Reports from North American customers indicated that a preliminary 'click' sound could occur, misleading users into believing the safety mechanism was fully activated before the shield securely locked. Despite this, no complaints or adverse event reports related to this specific issue were received from Chinese users.

Under the NMPA's regulatory framework, the company's required actions involve two main points. Firstly, while the products can continue to be used, BD Medical Devices is proactively distributing written customer letters to inform users about the identified issue. Secondly, the company strongly recommends that users strictly follow the product's instructions for use, particularly emphasizing the correct and immediate activation of the protective shield after injection to ensure complete needle tip coverage. Users are advised that if the protective shield fails to function properly, the needle tip should be immediately destroyed and the device discarded safely.