# China NMPA Product Recall - Disposable blood cell separator

Source: https://www.globalkeysolutions.net/records/china_product_recall/haemonetics-corporation/4d30480c-b88b-4a42-a5a1-9a7410fc7e7f
Source feed: China

> China NMPA product recall for Disposable blood cell separator by Haemonetics Corporation published August 29, 2017. Recall level: Level 3 Recall. Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall for its disposable blo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Weimei (Shanghai) Management Co., Ltd. has initiated a voluntary recall of disposable blood cell separators.
- Company Name: Haemonetics Corporation
- Publication Date: 2017-08-29
- Product Name: Disposable blood cell separator
- Recall Level: Level 3 Recall
- Recall Reason: There may be a potential risk of leakage when using the product with a 70ml centrifuge cup.
- Discovering Company: Weimei (Shanghai) Management Co., Ltd.
- Manufacturing Company: Haemonetics Corporation
- Summary: Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall for its disposable blood cell separators, as officially reported by the National Medical Products Administration (NMPA) on August 29, 2017. The decision to recall was made after the company identified a potential leakage risk specifically associated with the 70ml centrifuge cup component of the product. This critical issue affects disposable blood cell separators with registration number 20143456114, also noted under National Medical Device Import Registration No. 20143456113. The comprehensive details pertaining to the specific models, specifications, and affected product batches are thoroughly documented in the "Medical Device Recall Event Report Form," which serves as the primary attachment for this recall event. Additional related documents, such as those concerning "Single-Use Blood Cell Separator - Haemonetics Corporation," further support the recall information. This voluntary action taken by Weimei (Shanghai) Management Co., Ltd. highlights the company's commitment to ensuring the safety and reliability of its medical devices. The Class III designation for this recall indicates that the product defect, while significant, is unlikely to cause serious adverse health consequences but still warrants corrective action to prevent potential issues and maintain product quality standards. The NMPA oversees such recalls to protect public health and ensure compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/haemonetics-corporation/2039d730-deb9-4784-b573-e3f1f1682a27