China NMPA Product Recall - Disposable sterile injection needles and disposable sterile syringes (with needles)

On February 21, 2017, the National Medical Products Administration (NMPA) issued an index (JGXX-2017-10132) concerning a voluntary product recall initiated by BD Medical Devices (Shanghai) Co., Ltd. The company reported a significant safety concern involving its disposable sterile injection needles and disposable sterile syringes (with needles).

BD Medical Devices (Shanghai) Co., Ltd. discovered that certain batches of these products exhibited a critical defect: the protective covers could detach, causing the needle to protrude. This defect poses a substantial risk of needlestick injuries to users, which can lead to serious health implications. Due to the potential for severe adverse health consequences, this event was classified as a Level I recall, signifying the highest level of risk under the NMPA's regulatory framework.

In response to this identified safety issue, the company took proactive steps to protect public health by voluntarily recalling all affected products. The specific details, including the exact models, specifications, and batch numbers of the recalled disposable sterile injection needles and syringes, were documented in a "Medical Device Recall Event Report Form" accompanying the NMPA's announcement. This action underscores the company's commitment to product safety and compliance with regulatory standards.