China NMPA Product Recall - pressure pump

Condis (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for a specific pressure pump, identified by Registration No.: 201536623. This recall was officially announced by the National Medical Products Administration (NMPA) on July 14, 2017. The primary reason for this action was the potential for damage to the inner packaging plastic box of the affected products. Condis (Shanghai) Medical Devices Co., Ltd. proactively reported this issue. Under the NMPA's regulatory framework, the company is responsible for retrieving all affected units from the market. A Class II recall typically indicates that the product's use may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The damaged packaging could potentially compromise product integrity or sterility, necessitating the recall. Comprehensive details regarding the specific models, specifications, and batch numbers involved in this recall are provided in an accompanying "Medical Device Recall Event Report Form," which supports the NMPA's official notification.