# China NMPA Product Recall - Disposable sterile injection needles

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-medical-devices-shanghai-co-ltd/e0527142-6482-4b48-8bcc-88159b6edb67/
Source feed: China

> China NMPA product recall for Disposable sterile injection needles by Smith Medical Devices (Shanghai) Co., Ltd. published February 18, 2019. Recall level: Level 2 Recall. On February 18, 2019, BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall 

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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: 2019-02-18
- Product Name: Disposable sterile injection needles
- Recall Level: Level 2 Recall
- Recall Reason: This batch of disposable sterile injection needles contained a small number of blunt-tipped needles, among other issues.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Summary: On February 18, 2019, BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its disposable sterile injection needles (Registration Certificate No.: CFDA (Imported) 2014 No. 3154621). This action was taken in response to the discovery of a small quantity of blunt needles present within the packaging of specific batches of the affected product. The recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and was reported through the Shanghai Food and Drug Administration's Medical Device Recall 2019-029 notice. The primary issue identified was a manufacturing or packaging anomaly leading to the inclusion of defective needles, which poses a potential risk to patient safety if used. A Class II recall signifies that the product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, the company is voluntarily removing the affected products from the market. Further details regarding the specific models, specifications, and batch numbers subject to this recall are documented in the "Medical Device Recall Event Report Form," which stakeholders can access for comprehensive information. This proactive measure aims to mitigate potential health risks associated with the defective needles.

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