China NMPA Product Recall - BYS-820S Infusion Pump

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.