# China NMPA Product Recall - Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators; Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators

Source: https://www.globalkeysolutions.net/records/china_product_recall/weimei-shanghai-management-co-ltd/96a280f4-1437-4ad1-8350-f18bda11f5cf/
Source feed: China

> China NMPA product recall for Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators; Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators by Weimei (Shanghai) Management Co., Ltd. published October 30, 2019. Recall level: Level 3 Recall. On October 30, 2019, Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Weimei (Shanghai) Management Co., Ltd. is voluntarily recalling its disposable blood cell separators (Disposable Sets for Blood Apheresis System).
- Company Name: Weimei (Shanghai) Management Co., Ltd.
- Publication Date: 2019-10-30
- Product Name: Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators; Disposable Blood Apheresis Sets for Single-Use Blood Cell Separators
- Recall Level: Level 3 Recall
- Recall Reason: The product may have a potential risk of core leakage, which could cause liquid from inside the centrifuge cup to be introduced into the core during use, potentially triggering a "prolonged emptying" alarm. This issue can be detected by the equipment and an alarm will be issued.
- Discovering Company: Weimei (Shanghai) Management Co., Ltd.
- Manufacturing Company: Weimei (Shanghai) Management Co., Ltd.
- Summary: On October 30, 2019, Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Disposable Sets for Blood Apheresis System, identified by Registration Certificate Nos. 20143106114 and 20143106113. This action was prompted by internal complaint data analysis, which revealed a potential risk of core leakage in a small number of products. This defect could allow liquid from the centrifuge cup to enter its core during use, causing the associated medical equipment to trigger a 'prolonged emptying' alarm. The National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration oversaw this recall, designated as Medical Device Recall No. 2019-257. While the issue is detectable by the equipment's alarm system, and no adverse event feedback related to the affected batches had been received in China at the time of the recall, Weimei proactively moved to mitigate potential risks. The required action was a voluntary recall of all identified affected product models, specifications, and batches, with further details provided in an accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/weimei-shanghai-management-co-ltd/44cd0b8e-1da6-4c8a-906d-d1103aa4da6a/