# China NMPA Product Recall - Absorbable dressings for use with artificial skin

Source: https://www.globalkeysolutions.net/records/china_product_recall/gunji-medical-co-ltd/aa28b4e3-6a8a-4d18-a68b-85f4cadccdaf/
Source feed: China

> China NMPA product recall for Absorbable dressings for use with artificial skin by Gunji Medical Co., Ltd. published December 20, 2023. Recall level: Level 3 Recall. On December 20, 2023, the National Medical Products Administration (NMPA) announced a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kouno Medical Co., Ltd. has initiated a voluntary recall of its absorbable dressings containing artificial skin.
- Company Name: Gunji Medical Co., Ltd.
- Publication Date: 2023-12-20
- Product Name: Absorbable dressings for use with artificial skin
- Recall Level: Level 3 Recall
- Recall Reason: Incorrect label in instruction manual from overseas
- Discovering Company: Junshi Medical Equipment (Shenzhen) Co., Ltd.
- Manufacturing Company: Gunji Medical Co., Ltd.
- Summary: On December 20, 2023, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Gunze Medical Co., Ltd. The manufacturer is recalling its artificial skin product, utilized in absorbable dressings and registered under National Medical Device Registration Certificate No. 20163. The recall was reported by Gunze Medical Devices (Shenzhen) Co., Ltd., citing an error in the instruction manual label for products intended for overseas markets as the primary issue. A Class III recall signifies that while a deficiency exists, the use of or exposure to the affected product is unlikely to lead to serious adverse health consequences for patients or users. This proactive measure by Gunze Medical Co., Ltd. addresses a documentation inaccuracy rather than a product safety or performance defect. The company is committed to ensuring accurate product information across all markets. Detailed information concerning the specific models, specifications, and batch numbers of the recalled artificial skin is available in the "Medical Device Recall Event Report Form" attached to the NMPA's official notification. This action underscores the importance of precise labeling and adherence to regulatory standards for medical devices globally.

Company: https://www.globalkeysolutions.net/companies/gunji-medical-co-ltd/1ec7482c-da2e-44d7-b6e0-06971d9aa568/