China NMPA Product Recall - Non-absorbable surgical sutures

Chengdu Taihe Biomaterials Co., Ltd. announced a voluntary Class III recall for its non-absorbable surgical sutures, identified by Registration Code 20182650060. The specific affected batch, 0717, includes 750 units of model NLOWM42RS60D, intended for suturing and ligating human tissues during medical surgery. The company reported this recall on December 24, 2019, with the National Medical Products Administration (NMPA) publishing the details on December 27, 2019. The core issue leading to the recall is suspected non-compliance with the product's technical requirements, specifically related to its appearance. Operating under the NMPA's regulatory framework, Chengdu Taihe Biomaterials Co., Ltd. is mandated to implement several critical actions. These include an immediate halt to the sale and use of the entire affected batch of sutures. Furthermore, all distributed units must be returned to the manufacturer for consolidated handling, culminating in their centralized disposal. This proactive recall demonstrates the company’s commitment to addressing potential quality deviations and maintaining stringent product safety standards within the medical device industry.