China NMPA Product Recall - Postpartum Uterine Warming Patch

Ningxia Quanshui Pharmaceutical Co., Ltd. initiated a voluntary Level 3 recall of its Postpartum Uterus Care Patch (Batch No.: 20190225) on October 28, 2019. This action followed findings from the 2019 National Medical Device Spot Check Risk Monitoring, overseen by the National Medical Products Administration (NMPA). The primary issue identified was that the product failed to meet the temperature characteristics specified in section 4.6 of industry standard YY0060-91, and its heating time was also substandard, indicating a significant quality risk. The recall affects 4,850 boxes, with 4,825 having been sold domestically. As part of its corrective actions, Ningxia Quanshui Pharmaceutical Co., Ltd. issued recall notices to distributors, instructing them to cease sales immediately. The company committed to recalling all unused products from distributors for replacement and will conduct follow-up visits for products already used. Furthermore, the company plans to revise the technical requirements for the Postpartum Warming Uterus Patch, draft new temperature measurement methods and regulations aligned with the updated industry standard YY0060-2018 for heat therapy patches, and revise product instructions to clarify usage methods. The company will also acquire or develop appropriate temperature measuring devices to ensure future compliance. These steps aim to address the identified quality deficiencies and enhance product safety.