China NMPA Product Recall - Postpartum Uterine Warming Patch

Ningxia Quanshui Pharmaceutical Co., Ltd. initiated a voluntary Class III recall of its Postpartum Uterus Care Patch, as announced by the National Medical Products Administration (NMPA) on October 22, 2019. This action stemmed from a 2019 National Medical Device Spot Check that identified critical quality issues with specific batches of the product, including batch number 20190225.

The main violation involved the product's heating time and temperature characteristics, which failed to meet the requirements of the industry standard YY0060-91. This non-compliance posed a significant quality risk for a product designed to provide warming support for postpartum women and those who have had abortions.

In response to these findings, the company has committed to several required actions. These include issuing immediate recall notices to distributors to cease sales and retrieving all affected, unused products for replacement. For consumers who have already used the product, follow-up visits are planned. Additionally, Ningxia Quanshui Pharmaceutical Co., Ltd. will revise the product's technical requirements and temperature measurement methods, referencing the updated industry standard YY0060-2018. They will also amend the product instructions to clarify usage details like shaking times or duration, ensuring future compliance with specified temperature limits.