# China NMPA Product Recall - Membrane plasma separator

Source: https://www.globalkeysolutions.net/records/china_product_recall/asahi-kasei-medical-co-ltd/d3d93a43-bcc4-4eda-8dcb-2e9db7e2e649/
Source feed: China

> China NMPA product recall for Membrane plasma separator by Asahi Kasei Medical Co., Ltd. published October 30, 2017. Recall level: Level 3. Asahi Kasei Medical Systems Co., Ltd., in collaboration with its agent Beijing Jietong Kangnuo Pharm

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Asahi Kasei Medical Co., Ltd. voluntarily recalls membrane plasma separators.
- Company Name: Asahi Kasei Medical Co., Ltd.
- Publication Date: 2017-10-30
- Product Name: Membrane plasma separator
- Recall Level: Level 3
- Recall Reason: The membrane plasma separator was renewed for approval on January 13, 2017, with the new certificate number being 国械注进20173450240. However, our company discovered that the registration certificate number shown on the label of products manufactured in February and with batch number AG2B2N sold in China is still the old, continuation number. Therefore, our company has decided to implement a voluntary recall of this product. This recall is unrelated to product quality and safety.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Asahi Kasei Medical Co., Ltd.
- Summary: Asahi Kasei Medical Systems Co., Ltd., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., has initiated a voluntary Class III recall of its Membrane Plasma Separators. This recall, formally reported on October 24, 2017, and published by the National Medical Products Administration (NMPA) on October 30, 2017, addresses a labeling inconsistency. The primary issue identified was that products from batch number AG2B2N, manufactured in February 2017, were labeled with an outdated registration certificate number. Although the product's approval was renewed on January 13, 2017, under the new certificate number 国械注进20173450240, some units inadvertently displayed the previous number. The company explicitly stated that this discrepancy does not impact product quality or patient safety. To rectify this, Asahi Kasei Medical Systems Co., Ltd. has directed distributors to immediately cease sales of the affected products and return all inventory. Distributors are also required to provide sales information for the recalled units. Furthermore, the company confirmed that previously sold or used products present no safety concerns. All returned recalled products are slated for destruction, ensuring compliance with regulatory labeling standards.

Company: https://www.globalkeysolutions.net/companies/asahi-kasei-medical-co-ltd/d8951718-91ac-4194-9be5-387080581190/