# China NMPA Product Recall - Single-use platelet-to-leukocyte remover; Single-use red blood cell-to-leukocyte remover

Source: https://www.globalkeysolutions.net/records/china_product_recall/weimei-shanghai-management-co-ltd/30100b22-63a8-40ba-9155-2a9a0226a5b7/
Source feed: China

> China NMPA product recall for Single-use platelet-to-leukocyte remover; Single-use red blood cell-to-leukocyte remover by Weimei (Shanghai) Management Co., Ltd. published February 24, 2021. Recall level: Level 3 Recall. Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of specific single-use

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Weimei (Shanghai) Management Co., Ltd. is voluntarily recalling disposable platelet-leukocyte-reducing filters, disposable erythrocyte-leukocyte-reducing filters, and disposable erythrocyte-leukocyte-reducing filters.
- Company Name: Weimei (Shanghai) Management Co., Ltd.
- Publication Date: 2021-02-24
- Product Name: Single-use platelet-to-leukocyte remover; Single-use red blood cell-to-leukocyte remover
- Recall Level: Level 3 Recall
- Recall Reason: The issue arises because the expiration date format on some product certificates of conformity is year-month-day (the last day of the printed month), while the original manufacturer's label uses year-month (the last day of the printed month by default). This inconsistency is due to a software update in the production facilities. During this update, the factory revised the expiration date printed on the product certificates of conformity, but this same change was not applied to the product labels, resulting in this discrepancy. This issue does not affect product use and poses no health risk.
- Discovering Company: Weimei (Shanghai) Management Co., Ltd.
- Manufacturing Company: Weimei (Shanghai) Management Co., Ltd.
- Summary: Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of specific single-use medical filters, including platelet-leukocyte removal filters and red blood cell-leukocyte removal filters. This action, reported on February 24, 2021, and overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses an inconsistency in the expiration date format. The core issue arose from a software update at the production facility, which altered the expiration date format on product qualification certificates to "year-month-day" (specifying the last day of the month). However, this change was not applied to the product labels, which retained the "year-month" format (implicitly also meaning the last day of the month). This discrepancy, while present, is not reported to affect product safety or performance, and no related quality complaints have been received in China. Despite the absence of health risks, Weimei (Shanghai) Management Co., Ltd. is undertaking the recall to ensure full compliance and clarity for consumers and healthcare providers. The required action involves the voluntary removal of affected batches from circulation. Detailed information regarding specific models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form." This proactive measure demonstrates the company's commitment to regulatory standards under the NMPA's framework.

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