# China NMPA Product Recall - Disposable infusion pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-biot-medical-technology-co-ltd/e600b5a6-3b0c-4620-a0c7-79010a9d5090/
Source feed: China

> China NMPA product recall for Disposable infusion pump by Nanchang Biot Medical Technology Co., Ltd. published December 10, 2018. Recall level: Level 3 Recall. Nanchang Biot Medical Technology Co., Ltd. initiated a voluntary Class III recall of its disposable 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Biot Medical Technology Co., Ltd. voluntarily recalls disposable infusion pumps
- Company Name: Nanchang Biot Medical Technology Co., Ltd.
- Publication Date: 2018-12-10
- Product Name: Disposable infusion pump
- Recall Level: Level 3 Recall
- Recall Reason: Items such as average flow rate do not meet the standard requirements.
- Discovering Company: Nanchang Biot Medical Technology Co., Ltd.
- Manufacturing Company: Nanchang Biot Medical Technology Co., Ltd.
- Summary: Nanchang Biot Medical Technology Co., Ltd. initiated a voluntary Class III recall of its disposable infusion pumps (Medical Device Registration Certificate 20163542464), as publicized by the National Medical Products Administration (NMPA) on December 10, 2018. The primary issue prompting this recall was the failure of the infusion pumps to meet established standard requirements for average flow rate, indicating a critical performance deficiency. The NMPA, serving as the regulatory authority for medical products in China, oversees such actions to safeguard public health and ensure compliance within the medical device industry. While specific inspection dates leading to the discovery of this issue were not detailed in the recall announcement, the company's decision to conduct a voluntary recall underscores its responsibility to address product non-conformities. The required actions involve the company recalling all affected units, with comprehensive information on the specific models, product specifications, and manufacturing batches detailed in a separate "Medical Device Recall Event Report Form." This event emphasizes the importance of rigorous quality control and adherence to performance standards for medical devices.

Company: https://www.globalkeysolutions.net/companies/nanchang-biot-medical-technology-co-ltd/4591a757-6cd8-4053-b190-42bcbafdff64/