# China NMPA Product Recall - Importer

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-china-medical-trading-co-ltd/8ea75f28-a2f4-4ea9-b00a-7da71cab1904/
Source feed: China

> China NMPA product recall for Importer by Cook (China) Medical Trading Co., Ltd. published November 25, 2020. Recall level: Level 2 Recall. On November 25, 2020, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall f

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. is voluntarily recalling its implantation device.
- Company Name: Cook (China) Medical Trading Co., Ltd.
- Publication Date: 2020-11-25
- Product Name: Importer
- Recall Level: Level 2 Recall
- Recall Reason: The likelihood of proximal junction separation is increased in specific batches of injector products.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook (China) Medical Trading Co., Ltd.
- Summary: On November 25, 2020, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall for specific batches of its implant devices. This action was prompted by an identified increased possibility of separation at the proximal binding site of the affected products. The recall pertains to devices registered under Certificate Nos. 国械注进20173772039 and 国械注进20153030397, with detailed information on models and specifications provided in an accompanying Medical Device Recall Event Report Form.

The regulatory framework for this recall involves both the Shanghai Municipal Drug Administration, which reported the issue, and the National Medical Products Administration (NMPA), which published the announcement. A Class II recall signifies that the use of or exposure to the defective product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

The required action by Cook (China) Medical Trading Co., Ltd. is the comprehensive removal of these identified implant devices from the market. This proactive measure underscores the company's commitment to patient safety and adherence to the stringent medical device regulations enforced by Chinese authorities, aiming to mitigate potential risks associated with the product's structural integrity.

Company: https://www.globalkeysolutions.net/companies/cook-china-medical-trading-co-ltd/1ed3054b-44a7-4626-85e1-6402cb7ef9e0/