# China NMPA Product Recall - Disposable sterile injection needles

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-medical-devices-shanghai-co-ltd/2c4d308a-c7a5-44f5-949a-c84bf1f1499e/
Source feed: China

> China NMPA product recall for Disposable sterile injection needles by Smith Medical Devices (Shanghai) Co., Ltd. published February 22, 2019. Recall level: Level 2. BD Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary Class II recall concerning its dis

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary recall of disposable sterile injection needles.
- Company Name: Smith Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2019-02-22
- Product Name: Disposable sterile injection needles
- Recall Level: Level 2
- Recall Reason: This batch of disposable sterile injection needles contained a small number of blunt-tipped needles mixed in with some of the packaging.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Summary: BD Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary Class II recall concerning its disposable sterile injection needles. This significant action was publicly announced by the National Medical Products Administration (NMPA) on February 22, 2019. The affected products, identifiable by Registration Certificate No.: CFDA (Imported) 2014 No. 3154621, are subject to this recall due to unspecified issues. While the precise details necessitating the recall were not outlined in the provided public notice, a voluntary recall typically indicates a company's proactive measure to address potential quality or safety concerns before widespread issues arise, demonstrating a commitment to patient safety and product integrity. The NMPA, serving as the primary regulatory body for medical devices in China, oversees such actions to ensure compliance and public awareness. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Further detailed information regarding specific affected product models, specifications, and batch numbers was referred to in an accompanying 'Medical Device Notice' and a 'Medical Device Recall Event Report Form'. This regulatory action highlights the ongoing oversight by the NMPA to maintain high standards for medical devices within the Chinese market.

Company: https://www.globalkeysolutions.net/companies/smith-medical-devices-shanghai-co-ltd/a4f694b0-5671-4759-922c-b6adb96ecceb/