China NMPA Product Recall - Disposable surgical gowns

Xinxiang Rongjun Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable surgical gowns, as announced by the National Medical Products Administration (NMPA) on August 16, 2019. This action stemmed from findings during a national medical device spot check, which revealed that the tensile strength of the non-woven fabric used in the sleeves of the surgical gowns failed to meet required standards. Operating under the "Regulations on the Management of Medical Device Recalls," the company promptly conducted a risk assessment. This assessment determined that the identified non-conformity had not caused harm to human health. The affected batch consisted of 950 pieces, all of which were sold exclusively to Luoyang Jingyulin Medical Device Co., Ltd. By the time of the recall announcement, all products from this batch had been used, and no adverse events related to the defect were reported. Xinxiang Rongjun Medical Device Co., Ltd. has since implemented internal corrective and preventive measures to address the production non-conformity and prevent recurrence. The company's proactive response aims to ensure ongoing compliance and product safety.