China NMPA Product Recall - Warm and comfortable

Ningxia Youan Medical Device Co., Ltd. announced a voluntary Class III recall of its Nuanshu (暖舒) product, a medical device intended for women's reproductive health, specifically for conditions like menstrual disorders. This action was reported by the National Medical Products Administration (NMPA) on October 22, 2019. The primary reason for the recall is the product's non-compliance with essential performance standards, specifically regarding its heating time, the duration of heat, and its ability to maintain temperature. These deviations from standard requirements could impact the product's intended therapeutic effect and user safety. The recall affects batch number 2019040101, encompassing 3000 boxes of the product distributed within China. Operating under the regulatory framework of the NMPA, Ningxia Youan Medical Device Co., Ltd. is undertaking corrective measures. For all unused products, the company is mandated to uniformly assess their effectiveness to ensure consumer safety and product integrity. The recall notice and subsequent actions were duly submitted to the local Food and Drug Administration, underscoring the company's commitment to regulatory compliance and patient well-being in response to the identified quality concerns.