China NMPA Product Recall - Disposable surgical gowns

Jiangxi Shulan Jinhuan Medical Technology Co., Ltd. initiated a voluntary Class III recall of its disposable surgical gowns. This action, reported on August 14, 2019, under the oversight of the National Medical Products Administration (NMPA), was prompted by the discovery that the sleeve material of the affected gowns did not meet specified standard requirements. The company self-identified the issue, leading to the voluntary recall to ensure product safety and compliance. The specific product in question is identified by the approval number Gan Food and Drug Administration Medical Device (Approval) No. 20142640294. While no direct inspection dates are provided, the recall itself acts as a corrective measure following the identification of a non-conformance. The company is required to manage the recall process, including identifying and addressing all affected product models, specifications, and batches, detailed in their Medical Device Recall Event Report Form. This recall highlights the manufacturer's responsibility under NMPA regulations to ensure medical devices adhere to quality and performance standards throughout their lifecycle, taking proactive steps when deficiencies are identified.