# China NMPA Product Recall - Angiography catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/edd17e84-e63f-4138-a4ec-9b6bb30ed0e8/
Source feed: China

> China NMPA product recall for Angiography catheter by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published April 10, 2020. Recall level: Level 1 Recall. Boston Scientific International Medical Trade (Shanghai) Co., Ltd. has undertaken a voluntary Level 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of angiography catheters.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2020-04-10
- Product Name: Angiography catheter
- Recall Level: Level 1 Recall
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: Boston Scientific International Medical Trade (Shanghai) Co., Ltd. has undertaken a voluntary Level 1 recall of its angiography catheters, a critical medical device. This significant regulatory action was publicly reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The company initially filed a voluntary recall report on February 13, 2020, which was subsequently updated and publicized on April 10, 2020, under NMPA Index No. JGXX-2020-10212. The recall pertains to products manufactured under Registration Certificate No.: 20153774215. While the specific nature of the issue or violations necessitating this recall is not detailed in this public announcement, the 'Medical Device Recall Event Report Form,' referenced as an attachment, is stated to contain comprehensive information regarding the affected models, specifications, and batch numbers. A Level 1 recall signifies that there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. This voluntary action reflects the company's commitment to adhering to stringent medical device regulations and ensuring the safety and quality of its products within the Chinese market.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-international-medical-trade-shanghai-co-ltd/bc370948-4fe0-497a-93dd-bbac3a59dd56/