China NMPA Product Recall - Medical nasal splint

Shanghai Tashi Trading Co., Ltd. initiated a voluntary Class III recall of its medical nasal fixation splints on August 5, 2020. This action, reported under National Medical Products Administration (NMPA) Index No. JGXX-2020-10374 and a Shanghai Municipal Drug Administration notice, was prompted by a specific labeling deficiency.

The primary issue identified was the absence of Chinese instructions for certain batches of their medical nasal fixation splints (models SMNS-201-3 with batch numbers SP190918, SP190919; and SMNS-301-2 with batch numbers SP190920, SP190921). The company clarified that no other quality problems or adverse events were associated with the affected products.

Operating under the oversight of the NMPA and the Shanghai Municipal Drug Administration, Shanghai Tashi Trading Co., Ltd. proactively undertook this recall to address the non-compliance with regulatory requirements concerning product labeling. The required action involved the removal of the non-compliant batches from the market, with detailed product specifications available in the "Medical Device Recall Event Report Form." This voluntary recall demonstrates the company's commitment to regulatory adherence despite the absence of direct safety concerns related to product performance.