China NMPA Product Recall - Medical molecular sieve oxygen generator

Ningbo Jili Medical Device Co., Ltd. initiated a Class III voluntary recall of its Medical Molecular Sieve Oxygen Concentrators (Registration Certificate No.: Zheshiyaojianxie (Zhun) Zi 2014 No. 2540448). This action, reported on September 20, 2017, and subsequently publicized by the National Medical Products Administration (NMPA) on October 24, 2018, stemmed from findings during a national medical device quality supervision spot check. The primary issue identified was a labeling error on the product nameplate for the GE1-3L-W model, batch 20170202. The input power was incorrectly printed as 280VA, differing from the registered standard of 320VA. The company clarified that this was an administrative oversight and did not compromise the product's performance or safety.

To ensure full compliance with NMPA regulations, Ningbo Jili implemented a comprehensive corrective action plan for the 200 affected units. Labels for 40 units held in the warehouse were directly rectified. For 140 units sold to retail outlets, sales representatives were dispatched to perform on-site label replacements. Additionally, the company contacted end-users for 20 units to address the discrepancy. For the remaining 10 units where customers could not be reached, an advisory notice was issued, encouraging users to contact the company's national service hotline for a label replacement. This proactive recall demonstrates the company's commitment to regulatory adherence.