China NMPA Product Recall - absorbent cotton balls
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Chongqing Hongguan Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its Degreased Cotton Balls (Batch No. 20180802, Medium 500g, 100 packs) in December 2019. The recall was prompted by findings from the Chongqing Medical Device Quality Inspection Center, indicating that the products failed to meet critical technical requirements. Specifically, the degreased cotton balls exhibited substandard settling time and surfactant content. These quality deviations meant the products did not comply with the YY/T 0330-2015 "Medical Absorbent Cotton" standard and the company's internal product specifications (渝械备20150053号). Under the regulatory framework of the National Medical Products Administration (NMPA) of China, the company followed a structured recall process. This included the quality department initiating the recall, the sales department instructing customers to cease selling the affected products, and subsequently receiving and verifying returns for storage in a designated recall area. The ultimate required action for these non-conforming products is their destruction under the direct supervision of regulatory authorities, ensuring public safety and adherence to quality standards.
ID · c7125f80-679c-40a1-b050-1b3e2c926e39