China NMPA Product Recall - Medical disposable protective clothing (non-sterile type)

Hunan Xunzhuo Industrial Co., Ltd. initiated a voluntary Level 3 recall on September 14, 2020, for 100 units of its non-sterile disposable medical protective clothing, specifically batch number 20200417 (model One-piece 170). This action stemmed from a random inspection by the Anhui Provincial Bureau, which found the product's transverse tensile strength to be 43, failing to meet the registered product technical requirement of "not less than 45." This deviation indicated a non-compliance with established quality standards governed by the National Medical Products Administration (NMPA).In response, Hunan Xunzhuo Industrial Co., Ltd. formed a recall leadership team, confirmed no inventory remained with user units, and verified that no injuries to medical personnel had occurred. The company implemented several corrective actions, including segregating raw materials not yet produced, and plans to destroy non-conforming materials under regulatory supervision. Furthermore, the company conducted a comprehensive self-inspection, strengthened supplier auditing and management, and implemented corrective and preventive measures. Moving forward, Hunan Xunzhuo Industrial Co., Ltd. committed to strictly adhering to the "Good Manufacturing Practice for Medical Devices" to ensure product quality and regulatory compliance.