# China NMPA Product Recall - Diffused braided artificial blood vessels

Source: https://www.globalkeysolutions.net/records/china_product_recall/intervascular-sas/f70959ca-8a05-450d-888d-b9edde2e9b80/
Source feed: China

> China NMPA product recall for Diffused braided artificial blood vessels by InterVascular SAS published February 21, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intel Vanscora Inc.'s Intervascular SAS is voluntarily recalling bifid braided artificial blood vessels.
- Company Name: InterVascular SAS
- Publication Date: 2023-02-21
- Product Name: Diffused braided artificial blood vessels
- Recall Level: Level 2 Recall
- Recall Reason: There is a slight underdosing of the sterilizing agent.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: InterVascular SAS
- Summary: The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initiated by Intel Vanscolar Inc.'s Intervascular SAS, reported through Maikewei (Shanghai) Medical Equipment Co., Ltd. This recall, published on February 21, 2023, pertains to specific models and batches of Intel Vanscolar Inc.'s Intervascular SAS dual-braided artificial blood vessels (Registration Certificate No.: 20173130601). The primary issue prompting this action is a slight deficiency in the sterilizing agent dosage observed in the identified products. This deviation raises concerns regarding the sterility assurance of these medical devices. Under the regulatory oversight of the NMPA, a Class II recall signifies that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a required action, Intel Vanscolar Inc.'s Intervascular SAS is voluntarily recalling the affected products to mitigate potential risks to patient safety. Further specific details regarding the impacted product models, specifications, and batch numbers are documented in the accompanying "Medical Device Recall Event Report Form." This voluntary recall demonstrates the company's commitment to product safety and compliance with NMPA's regulatory standards.

Company: https://www.globalkeysolutions.net/companies/intervascular-sas/99a835b0-6697-407d-9fb0-6713691eb14c/