# China NMPA Product Recall - Concentrates for hemodialysis and related treatments

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-heting-trading-co-ltd/e3c5b7b0-bd76-4011-a468-8fe8e4405b95/
Source feed: China

> China NMPA product recall for Concentrates for hemodialysis and related treatments by Shanghai Heting Trading Co., Ltd. published October 28, 2021. Recall level: Level 3 Recall. Shanghai Heting Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis and rel

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Heting Trading Co., Ltd. has voluntarily recalled its hemodialysis and related therapeutic concentrates.
- Company Name: Shanghai Heting Trading Co., Ltd.
- Publication Date: 2021-10-28
- Product Name: Concentrates for hemodialysis and related treatments
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were affected because, between August 16, 2020 and July 30, 2021, the malfunctions in the production water pipelines were not promptly corrected and rectified.
- Discovering Company: Shanghai Heting Trading Co., Ltd.
- Manufacturing Company: Shanghai Heting Trading Co., Ltd.
- Summary: Shanghai Heting Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis and related therapeutic concentrates. This action, reported by the National Medical Products Administration (NMPA) on October 28, 2021, stems from a critical manufacturing issue identified within the company's operations. The primary violation involved the failure to promptly address and rectify malfunctions in the production water pipeline over an extended period, specifically from August 16, 2020, to July 30, 2021. As a result of this lapse in quality control, Shanghai Heting Trading Co., Ltd. determined it necessary to recall all affected products manufactured during the specified timeframe. The recall encompasses hemodialysis and related therapeutic concentrates, identified by Registration Certificate No.: 20163451474. The company's decision to conduct a voluntary Level III recall underscores the seriousness of the issue. Further details regarding specific product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" attachment referenced by the NMPA. This incident highlights the importance of rigorous adherence to manufacturing process integrity under the NMPA's oversight.

Company: https://www.globalkeysolutions.net/companies/shanghai-heting-trading-co-ltd/da8183fc-ea57-4068-98fd-a69da52dc970/