# China NMPA Product Recall - Disposable infusion pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhejiang-haisheng-medical-equipment-co-ltd/5ffdf6b3-0367-4059-b173-55689786b33e/
Source feed: China

> China NMPA product recall for Disposable infusion pump by Zhejiang Haisheng Medical Equipment Co., Ltd. published January 17, 2019. Recall level: Level 3. Zhejiang Chenhe Medical Equipment Co., Ltd. initiated voluntary Class III recalls for two models of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zhejiang Chenhe Medical Equipment Co., Ltd. voluntarily recalls disposable infusion pumps.
- Company Name: Zhejiang Haisheng Medical Equipment Co., Ltd.
- Publication Date: 2019-01-17
- Product Name: Disposable infusion pump
- Recall Level: Level 3
- Recall Reason: The ultraviolet absorbance of the product was found to be substandard during the national medical device supervision and spot check.
- Discovering Company: Zhejiang Chenhe Medical Equipment Co., Ltd.
- Manufacturing Company: Zhejiang Haisheng Medical Equipment Co., Ltd.
- Summary: Zhejiang Chenhe Medical Equipment Co., Ltd. initiated voluntary Class III recalls for two models of its Disposable Infusion Pumps, PCA-100C and PCA-200B, following findings from the National Medical Products Administration (NMPA) of China. The recalls were reported on August 27, 2018, and August 3, 2018, respectively.
The primary issue identified through national medical device sampling inspections was that both pump models failed to meet quality standards due to unqualified ultraviolet (UV) absorbance. Specifically, batch 20170411 of the PCA-100C model, intended for continuous micro-dose and patient-controlled infusion in postoperative analgesia, was found deficient by the Jiangsu Provincial Medical Device Inspection Institute. Similarly, batch 20180314 of the PCA-200B model exhibited substandard UV absorbance, as determined by the Beijing Medical Device Inspection Institute.
To address these non-conformities under the NMPA's regulatory framework, Zhejiang Chenhe Medical Equipment Co., Ltd. implemented several corrective actions. These included promptly issuing recall notices to affected customers, conducting re-sampling and self-inspections of existing inventory for UV absorbance, outsourcing further testing of the infusion pumps' UV absorbance, and initiating investigations into the root causes of the quality failures. These steps aim to ensure compliance and product safety.

Company: https://www.globalkeysolutions.net/companies/zhejiang-haisheng-medical-equipment-co-ltd/f4b969e9-b631-4e2a-b4f8-ee5c72690d2b/