# China NMPA Product Recall - sterile surgical membrane

Source: https://www.globalkeysolutions.net/records/china_product_recall/shandong-kunao-medical-technology-co-ltd/8dbbde38-2f6e-4855-b26a-693cddee9ba9/
Source feed: China

> China NMPA product recall for sterile surgical membrane by Shandong Kun"ao Medical Technology Co., Ltd. published December 29, 2021. Recall level: Level III. Shandong Sukang Medical Technology Co., Ltd. initiated a voluntary Class III recall of its Disposabl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shandong Sukang Medical Technology Co., Ltd. has initiated a voluntary recall of disposable sterile surgical membranes.
- Company Name: Shandong Kun"ao Medical Technology Co., Ltd.
- Publication Date: 2021-12-29
- Product Name: sterile surgical membrane
- Recall Level: Level III
- Recall Reason: In 2021, the water vapor permeability index of medical devices failed to meet the technical requirements of the national medical device supervision and spot check.
- Discovering Company: Shandong Sukang Medical Technology Co., Ltd.
- Manufacturing Company: Shandong Kun"ao Medical Technology Co., Ltd.
- Summary: Shandong Sukang Medical Technology Co., Ltd. initiated a voluntary Class III recall of its Disposable Sterile Surgical Membranes. This action, reported by the National Medical Products Administration (NMPA) on December 29, 2021, stems from the 2021 National Medical Device Supervision and Inspection. The primary issue identified was that the product's water vapor permeability index failed to meet the established technical requirements. The affected products, registered under No. Lu Xie Zhu Zhun 20142640259, were subject to this regulatory intervention. A Class III recall indicates that the product's use is unlikely to cause adverse health consequences, but the deviation from technical specifications necessitates its removal from circulation. This measure, overseen by the NMPA and the Shandong Provincial Drug Administration, underscores the commitment to ensuring product quality and public safety in the medical device sector. Further details on specific models, specifications, and batch numbers are available in the 'Medical Device Recall Event Report Form'.

Company: https://www.globalkeysolutions.net/companies/shandong-kunao-medical-technology-co-ltd/7900d2e9-1615-452e-a0ed-c110645d3372/