# China NMPA Product Recall - Integrated membrane oxygenator, arterial filter, and venous blood storage device (Models: VKMO 10000 and VKMO 11000)

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/aed3cbfc-0175-4d33-bb05-7f18dfeac92b/
Source feed: China

> China NMPA product recall for Integrated membrane oxygenator, arterial filter, and venous blood storage device (Models: VKMO 10000 and VKMO 11000) by Maikewei (Shanghai) Medical Equipment Co., Ltd. published May 20, 2019. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Level II recall for specific i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maco (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling integrated membrane oxygenators, arterial filters, and venous blood storage devices.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2019-05-20
- Product Name: Integrated membrane oxygenator, arterial filter, and venous blood storage device (Models: VKMO 10000 and VKMO 11000)
- Recall Level: Level 2 Recall
- Recall Reason: Leakage at the blood inlet may render it unusable.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Level II recall for specific integrated membrane oxygenators, arterial filters, and venous blood storage devices. This action, published by the National Medical Products Administration (NMPA) on May 20, 2019, addresses a critical manufacturing defect. The affected products, registered under Certificate No. 20163454677, specifically models VKMO 10000 and VKMO 11000, were found to have a "leaking blood inlet." This issue poses a risk of malfunction, which could compromise device performance and patient safety. Operating under the regulatory framework of the NMPA and the Shanghai Food and Drug Administration, Maikewei decided to recall the products to mitigate potential harm. A Level II recall indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in an attached "Medical Device Recall Event Report Form" to facilitate compliance and ensure effective removal of the affected devices from circulation.

Company: https://www.globalkeysolutions.net/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9/