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

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-and-company/3261d665-34e6-40e6-86f7-72c0a5f17399/
Source feed: China

> China NMPA product recall for Single-use sterile injection needles; single-use sterile syringes with needles by Becton, Dickinson and Company published February 21, 2017. Recall level: I. BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton Dickinson and Company, initiated a L

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling disposable sterile injection needles and disposable sterile syringes (with needles).
- Company Name: Becton, Dickinson and Company
- Publication Date: 2017-02-21
- Product Name: Single-use sterile injection needles; single-use sterile syringes with needles
- Recall Level: I
- Recall Reason: Customers in BD North America have reported that, in some cases, the protective shield of our products may detach when pushed toward the needle, exposing the needle and increasing the risk of needlestick injury. Some users in North America have reported hearing a "click" sound before the protective shield locks when the safety device is activated, followed by a second "click" sound when the shield locks onto the needle. The first "click" sound does not indicate that the protective shield is fully locked.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton, Dickinson and Company
- Summary: BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton Dickinson and Company, initiated a Level I voluntary recall for specific batches of its disposable sterile injection needles and disposable sterile syringes with needles. This recall was publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017, following the company's internal report dated December 29, 2016. The primary issue prompting this action is the potential for the protective shield on these devices to detach when activated, exposing the needle and significantly increasing the risk of needlestick injuries. Customer reports, primarily from North America, indicated that a preliminary "click" sound during activation might not signify a fully locked protective shield. While no complaints or adverse events related to this specific issue were reported in China, the company's corrective actions include advising customers that products can continue to be used, provided users strictly adhere to the instructions for use. Specifically, users must ensure the protective shield is fully engaged immediately after injection and that the needle tip is completely covered. BD Medical Devices also committed to proactively sending written customer letters to inform them of the incident, emphasizing proper usage protocols.

Company: https://www.globalkeysolutions.net/companies/becton-dickinson-and-company/584ebc66-20ed-4c0c-8447-169c00c667fd/