China NMPA Product Recall - Absorbable sutures (brand name: VICRYL Plus)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its absorbable sutures, specifically those marketed under the trade name VICRYL Plus. This regulatory action was officially reported on March 18, 2019, through notices issued by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA). The primary issue identified was that certain models and batches of the VICRYL Plus sutures contained products that were inconsistent with their respective sales unit packaging and aluminum foil labels. This discrepancy raised concerns regarding accurate product identification and proper use. As a required action, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is undertaking this Class II recall to address the inconsistency and ensure the integrity and safety of its medical devices. The Class II designation indicates that the product's use may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse consequences is remote. Further detailed information regarding the affected models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form."