# China NMPA Product Recall - Disposable hollow fiber high-flux dialyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangsu-langsheng-life-technology-co-ltd/8dec15c0-54fd-4290-9d10-eb7ba0a3df5f/
Source feed: China

> China NMPA product recall for Disposable hollow fiber high-flux dialyzer by Jiangsu Langsheng Life Technology Co., Ltd. published November 08, 2018. Recall level: Level 3. Jiangsu Langsheng Life Technology Co., Ltd. initiated a voluntary Class III recall of its disposable

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangsu Langsheng Life Technology Co., Ltd. is voluntarily recalling disposable hollow fiber high-flux dialyzers.
- Company Name: Jiangsu Langsheng Life Technology Co., Ltd.
- Publication Date: 2018-11-08
- Product Name: Disposable hollow fiber high-flux dialyzer
- Recall Level: Level 3
- Recall Reason: The batch of products caused dialysis reactions such as low blood pressure during use at a hospital in Guangzhou.
- Discovering Company: Jiangsu Langsheng Life Technology Co., Ltd.
- Manufacturing Company: Jiangsu Langsheng Life Technology Co., Ltd.
- Summary: Jiangsu Langsheng Life Technology Co., Ltd. initiated a voluntary Class III recall of its disposable hollow fiber high-fluidity dialyzers (Registration Certificate Code: 国械注准20153450479). The recall was reported to the National Medical Products Administration (NMPA) on November 2, 2018. This action followed reports of adverse dialysis reactions, specifically hypotension, experienced by patients using product batch number 1809034 at a hospital in Guangzhou. The company identified 1283 units produced and 763 units sold in China from the affected batch. The regulatory framework for this recall is established by the NMPA, which categorizes it as a Class III recall, indicating a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. As part of the required actions, user units were instructed to immediately cease the use of the implicated batch (1809034) of dialyzers. Furthermore, all existing inventory of these products must be returned to Jiangsu Langsheng Life Technology Co., Ltd. Upon receipt, the returned products will undergo retesting by the company and will be processed according to the results of these evaluations to ensure patient safety and product quality compliance.

Company: https://www.globalkeysolutions.net/companies/jiangsu-langsheng-life-technology-co-ltd/716772ca-0cb2-4401-8f0d-ef2a9595fae7/