# China NMPA Product Recall - Infusion pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/changshu-beyond-medical-device-co-ltd/addf9f9a-9fcf-49e8-ba91-ded6f3e0d003/
Source feed: China

> China NMPA product recall for Infusion pump by Changshu Beyond Medical Device Co., Ltd. published July 19, 2017. Recall level: Level 3 Recall. Changsha Biyang Medical Device Co., Ltd. initiated a Class III voluntary recall of its Infusion Pump

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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: 2017-07-19
- 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-core power socket needs to be indicated in the instruction manual as "吉" for functional grounding; and the interval between the "low power" alarm prompt and the machine stopping when the battery is depleted is too short when the machine's built-in battery is used alone (without external power supply).
- Discovering Company: Changsha Biyang Medical Device Co., Ltd.
- Manufacturing Company: Changshu Beyond Medical Device Co., Ltd.
- Summary: Changsha Biyang Medical Device Co., Ltd. initiated a Class III voluntary recall of its Infusion Pump, model BYS-820S, under the oversight of the National Medical Products Administration (NMPA). This recall, reported in September 2016 and published in July 2017, was prompted by several identified non-conformities affecting 50 manufactured/imported units, with 9 units sold in China. The primary issues included incorrect nameplate markings (requiring a change from a DC to an AC symbol), insufficient clarity in the instruction manual regarding functional grounding for the three-pin power socket (needing an upgrade to include the appropriate symbol), and an inadequate interval between the "low battery" alarm and the device stopping when operating on internal battery power. In response, Changsha Biyang Medical Device Co., Ltd. is undertaking corrective actions: modifying nameplate markings, revising the instruction manual to incorporate the functional grounding symbol, conducting individual testing of each unit, and adjusting machine parameters for those with inadequate battery discharge times. No customer complaints or adverse events related to these issues have been reported.

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