China NMPA Product Recall - Lead Vest

Shandong Shuangying Medical Device Co., Ltd. initiated a voluntary Class III recall of its lead vests (Registration Certificate No.: Lu Yan Xie Bei 20160050) on June 11, 2019, as published by the National Medical Products Administration (NMPA). The primary issue identified was the absence of required X-ray tube voltage markings on the medical devices, an essential safety and regulatory compliance detail for products intended for X-ray protection. While no specific inspection dates were provided, this voluntary action highlights the company's response to the detected non-compliance.

The recall applied to a specific batch, Pb-2018-03, which included 20 units. Of these, 11 vests had been distributed to customers, one was used for sampling, and eight remained within the company's inventory. As a corrective measure, Shandong Shuangying Medical Device Co., Ltd. immediately modified the eight un-shipped vests by adding the necessary X-ray tube voltage markings and updating their associated instructions. For the 11 units already sold, revised instructions incorporating the missing information were promptly sent to the customers. This action demonstrates the company's commitment to rectifying product deficiencies and adhering to NMPA's regulatory framework for medical device safety and labeling.