# China NMPA Product Recall - BYS-820S Infusion Pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/changshu-beyond-medical-device-co-ltd/93fe4b57-f9b2-40cc-bdbf-81cd2c2af85b/
Source feed: China

> China NMPA product recall for BYS-820S Infusion Pump by Changshu Beyond Medical Device Co., Ltd. published July 18, 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: 2017-07-18
- Product Name: BYS-820S 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 "吉" (ji) being the functional grounding; 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 customer complaints or adverse events have been received to date.
- 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), as announced by the National Medical Products Administration (NMPA) on July 18, 2017. The recall stemmed from identified non-conformities related to the product's design and documentation.Key issues included incorrect external nameplate markings, where a DC symbol needed replacement with an AC symbol. Additionally, the instruction manual required an update to clearly indicate the functional grounding symbol for the three-pin power socket. A significant concern was the inadequate interval between the "low battery" audible alarm and the device cessation when operating solely on its internal battery, posing a potential risk to patient treatment continuity. Fortunately, no customer complaints or adverse events linked to these issues were reported.The recall affected 50 manufactured units, with 9 having been sold within China. Under the NMPA's regulatory oversight, Changsha Biyang Medical Device Co., Ltd. committed to specific corrective actions. These included revising the nameplate markings, updating the instruction manual to feature the correct grounding symbol, and individually testing each affected machine. For any devices failing to meet battery discharge time specifications, parameter adjustments were mandated to ensure compliance and patient safety.

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