# China NMPA Product Recall - Guidance tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/contis-shanghai-medical-devices-co-ltd/3a97ade4-9f9a-484a-b89d-cc71425c72d3/
Source feed: China

> China NMPA product recall for Guidance tube by Contis (Shanghai) Medical Devices Co., Ltd. published February 25, 2019. Recall level: Level 2 Recall. On February 25, 2019, Condis (Shanghai) Medical Device Co., Ltd. initiated a voluntary Class II reca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Contis (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its guiding catheters.
- Company Name: Contis (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2019-02-25
- Product Name: Guidance tube
- Recall Level: Level 2 Recall
- Recall Reason: In rare cases, fragments of the outer packaging, damaged or worn, entered the aseptic packaging plastic bag. These fragments of the outer packaging were visible inside the aseptic packaging.
- Discovering Company: Contis (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Contis (Shanghai) Medical Devices Co., Ltd.
- Summary: On February 25, 2019, Condis (Shanghai) Medical Device Co., Ltd. initiated a voluntary Class II recall of its guiding tubes, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall involves products with Registration Certificate Nos. 20153771031 and 20183032568. The primary issue prompting this action was the discovery of a small number of fragments from worn outer packaging that had entered and become visible inside the sterile plastic bags. This defect compromises the sterility and integrity of the medical devices. Condis (Shanghai) Medical Device Co., Ltd. proactively took steps to remove the affected products from the market to mitigate any potential risks associated with the packaging breach. Detailed information regarding the specific product models, specifications, and batches involved in the recall is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/contis-shanghai-medical-devices-co-ltd/17e6f919-5d81-4fa7-b459-0a5ef5a882ca/