China NMPA Product Recall - Infusion pumps (models AJ5808, AJ5808A)

On July 24, 2019, the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration announced that Shanghai Anjie Electronic Equipment Co., Ltd. initiated a voluntary Class III recall of its infusion pumps. The affected models include AJ5808 and AJ5808A, registered under Certificate No.: 20162540649. The primary reason for this recall is a critical labeling discrepancy identified on the devices' power switches. The company determined a need to modify the marking from what was originally designated as the 'main power switch' to an 'internal power switch.' This modification is essential for ensuring accurate identification and proper operation of the medical devices, thereby enhancing user safety and compliance with established medical device standards. This proactive measure by Shanghai Anjie Electronic Equipment Co., Ltd. underscores their commitment to product quality and adherence to regulatory requirements. A Class III recall addresses situations where the probability of adverse health consequences from product use or exposure is low. Comprehensive details concerning the specific models, specifications, and batches involved in this recall are provided in the company's official 'Medical Device Recall Event Report Form.' The recall process is designed to ensure that all affected units are updated to meet the necessary labeling specifications.