China NMPA Product Recall - Medical cotton balls

On December 16, 2019, the National Medical Products Administration (NMPA) announced that Henan Yadu Industrial Co., Ltd. initiated a voluntary Level III recall of certain medical cotton balls. This action followed a National Medical Device Sampling Inspection, which identified that batch number 184133 (LSH: 331841085) of their medical cotton balls failed to meet required standards due to non-compliant levels of surface-active substances. The affected product, "Medical Cotton Balls" with registration code 豫械注准20152640039, is typically used with disinfectant solutions for skin or instrument disinfection. Approximately 6,000 packs of the medium-sized, 5-capsule/pack product were sold in China. In response to these findings and in accordance with NMPA regulations, Henan Yadu Industrial Co., Ltd. is required to take several corrective actions. These include promptly notifying all purchasers and users to cease selling and using the implicated batch, and ensuring a comprehensive recall of all affected products from the market. Furthermore, the company must conduct a thorough investigation to determine the root causes of the non-compliance, develop appropriate corrective measures, and implement them effectively to prevent recurrence. This ensures product quality and patient safety within the regulatory framework.