# China NMPA Product Recall - Infusion pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/changshu-beyond-medical-device-co-ltd/d320f314-c88c-4cc5-9cd0-194b77c427c4/
Source feed: China

> China NMPA product recall for Infusion pump by Changshu Beyond Medical Device Co., Ltd. published June 05, 2017. Recall level: Level 3 Recall. Changsha Biyang Medical Device Co., Ltd. has voluntarily initiated a Class III recall for its infusi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changsha Biyang Medical Device Co., Ltd. voluntarily recalls infusion pumps
- Company Name: Changshu Beyond Medical Device Co., Ltd.
- Publication Date: 2017-06-05
- Product Name: Infusion pump
- Recall Level: Level 3 Recall
- Recall Reason: The nameplate markings on the infusion pump (BYS-820S) need to be modified; the protective grounding of the three-pin power socket needs to be clearly indicated in the instruction manual as "±" being the functional ground; and the interval between the "low power" alarm and the machine stopping when the built-in battery is used alone (without external power) is too short. No complaints or reports of adverse events have been received from customers regarding these issues.
- Discovering Company: Changsha Biyang Medical Device Co., Ltd.
- Manufacturing Company: Changshu Beyond Medical Device Co., Ltd.
- Summary: Changsha Biyang Medical Device Co., Ltd. has voluntarily initiated a Class III recall for its infusion pumps (Model BYS-820S, Registration No. 湘食药监械（准）字2014第2540079号) under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The recall, reported on September 28, 2016, addresses several manufacturing non-conformities identified by the company. Key issues include incorrect external markings on equipment components, specifically the nameplate displaying a DC symbol where an AC symbol was required. Additionally, the instruction manual failed to clearly indicate the protective grounding for the three-pin power socket. A significant concern was also identified with the device's audible alarm system, where the interval between the "low battery" alarm and the machine's automatic shutdown was excessively short when operating on internal battery power. In response, Changsha Biyang Medical Device Co., Ltd. committed to corrective actions including updating nameplate markings, revising the instruction manual to incorporate the grounding indicator, adjusting machine parameters for units with non-compliant battery discharge, and conducting individual testing on each machine to ensure compliance. The company confirmed that no customer complaints or adverse events have been reported related to these issues.

Company: https://www.globalkeysolutions.net/companies/changshu-beyond-medical-device-co-ltd/ccd63222-22c9-4bf0-b3b7-4866e0a8facd/