# China NMPA Product Recall - Mechanical release spring coil system

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiaqi-biotechnology-shanghai-co-ltd/887e34d1-d0be-44f2-9292-846b677f50d8/
Source feed: China

> China NMPA product recall for Mechanical release spring coil system by Jiaqi Biotechnology (Shanghai) Co., Ltd. published December 18, 2019. Recall level: Level 3 Recall. Jiaqi Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its mechanical r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiaqi Biotechnology (Shanghai) Co., Ltd. is voluntarily recalling its mechanical release coil system.
- Company Name: Jiaqi Biotechnology (Shanghai) Co., Ltd.
- Publication Date: 2019-12-18
- Product Name: Mechanical release spring coil system
- Recall Level: Level 3 Recall
- Recall Reason: The silicone plug (removable) securing the handle gap of the mechanical release spring coil system has a 7% chance of falling out into the paper-plastic bag under external force.
- Discovering Company: Jiaqi Biotechnology (Shanghai) Co., Ltd.
- Manufacturing Company: Jiaqi Biotechnology (Shanghai) Co., Ltd.
- Summary: Jiaqi Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its mechanical release coil system, a medical device, on December 18, 2019. The company discovered that a removable silicone plug, which secures the device's handle gap, could detach and fall into the product's packaging under external force. While Jiaqi Biotechnology clarified that this issue does not pose a direct risk to human health, the recall was deemed necessary to maintain product quality assurance standards. This action was taken within the regulatory framework overseen by the National Medical Products Administration (NMPA), under whose registration certificate the product operates, and reported to the Shanghai Municipal Drug Administration. The company's required action involves retrieving affected products from the market, with comprehensive details regarding specific models, specifications, and batch numbers provided in an accompanying Medical Device Recall Event Report Form. This demonstrates the company's commitment to stringent quality control and compliance with NMPA guidelines.

Company: https://www.globalkeysolutions.net/companies/jiaqi-biotechnology-shanghai-co-ltd/215a91ca-b7ce-49e0-ac9a-8ddf80f0afb6/