# 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/05988993-fafb-40e2-bac2-7c1aa05774f1/
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: . BD Medical Devices (Shanghai) Co., Ltd., on behalf of Becton Dickinson and Company, initiated a volu

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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 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., on behalf of Becton Dickinson and Company, initiated a voluntary Level 3 recall of disposable sterile injection needles and disposable sterile syringes with needles. This recall was reported on December 29, 2016, and publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017. The main issue identified was that the protective shield on certain Eclipse™ needles could detach when activated, exposing the needle and increasing the potential for needlestick injuries to users. While this concern originated from customer reports in North America, no related complaints or adverse events were reported in China.

The recall encompasses 137,450 units globally, with 44,400 units distributed within China, covering various models and specifications of the affected devices. As part of its corrective actions under NMPA guidelines, BD Medical Devices has advised that products may continue to be used. Concurrently, the company is proactively communicating with customers through written notices. These communications underscore the necessity of strictly following the product's instructions for use, particularly the immediate and correct activation of the protective shield after injection to ensure the needle tip is fully covered, and proper disposal of any device where the shield fails to function.

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