China NMPA Product Recall - Medical molecular sieve oxygen generator

Ningbo Jili Medical Device Co., Ltd. initiated a voluntary Level 3 recall for its Medical Molecular Sieve Oxygen Concentrators (Registration Certificate No.: Zheshiyaojianxie (Zhun) Zi 2014 No. 2540448). This action, reported to the National Medical Products Administration (NMPA) on October 23, 2018, followed a national medical device quality supervision and spot check. The primary issue identified was a labeling error on the product nameplate, where the input power was incorrectly printed as 280VA instead of the actual registered standard of 320VA. The company clarified that this discrepancy is solely a labeling issue and does not impact the product's performance or safety. The affected batch, identified as 20170202, involved 200 units, with 160 units sold in China. In response to this regulatory non-compliance, Ningbo Jili Medical Device Co., Ltd. undertook several corrective actions. Forty units remaining in inventory were rectified. For the 140 units distributed to retail outlets, sales representatives were deployed to replace the incorrect product labels. Out of 20 units sold directly to end-users, customers were successfully contacted and their units rectified. The company has also issued an advisory notice and provided a national service hotline (4008868665) to reach the remaining 10 end-users who could not be contacted, instructing them on the label replacement process.