China NMPA Product Recall - Line

On August 26, 2016, the National Medical Products Administration (NMPA) in China issued a notice regarding a voluntary recall initiated by Ethicon, LLC, a manufacturer under Johnson & Johnson. The recall concerned several models of suture straps, including RS20, RS21, RS22, RS23, and various D-series models. The primary issue identified was a labeling error, where the suture straps were incorrectly accompanied by MERSILENETM labels or instructions for use. These suture straps are intended for applications such as circumferential sutures of the cervix or as traction and fixation straps during surgical procedures. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the responsible unit in China, confirmed that none of the affected batches of these products were imported into or sold within China. Consequently, the recall does not require any direct corrective actions or product retrieval within the Chinese market. As a regulatory measure, the NMPA requested that food and drug administrations across all provinces, autonomous regions, and municipalities strengthen their supervision of such products to ensure compliance and public safety. This document highlights a global recall's impact, clarifying that while a labeling discrepancy occurred, the Chinese market remained unaffected due to no product distribution.