China NMPA Product Recall - Pressure pump (Encore26)

The National Medical Products Administration (NMPA) published a voluntary recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. on July 14, 2017. The recall pertains to their Pressure Pump (Encore26), identified by NMPA Import Registration No. 20133663453. The primary issue prompting this action is the potential damage to the aseptic packaging (transparent part) of the affected products. While specific inspection dates are not detailed in the provided document, the recall itself was announced on the aforementioned date. This is classified as a Class II recall, indicating a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. As a required action under NMPA regulations, Boston Scientific is voluntarily recalling the affected units to address this packaging integrity issue and ensure product safety. Further details regarding specific models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" attachment.