China NMPA Product Recall - Electric anti-bedsore air mattress

Chongqing Huabo Junwei Pharmaceutical Co., Ltd. initiated a voluntary Level III recall of its Electric Anti-Decubitus Air Mattress (registration number: Yu 20182560057) following a Chongqing Municipal Supervision and Inspection on May 15, 2019. The primary issue identified was that the controller display on specific units, such as JWM85017061007, showed the unit "kg" (kilogram), which deviates from the International System of Units (SI) requirements stipulated in GB3100 and the supplementary unit requirements of GB9706.1-2007. Under the guidance of the National Medical Products Administration (NMPA) framework, the company's corrective actions include a multi-step process. The sales department is tasked with tracing and quantifying affected products. Subsequently, the quality control department will develop a comprehensive "Recall Investigation and Evaluation Plan" and a "Recall Implementation Plan," detailing the scope, methodology, timeline, communication strategy, and post-recall measures. The management representative is responsible for submitting all pertinent recall documentation, including the "Medical Device Recall Event Report Form," to the State Drug Administration for official record-keeping. Finally, the sales department will issue formal recall notices to customers, with the quality management department overseeing the implementation and verifying the efficacy of these communications. The recall report was dated November 6, 2019, with the public announcement on December 2, 2019.