China NMPA Product Recall - Non-absorbable sutures (with/without needle) (brand name: Aishibang) and non-absorbable sutures (brand name: Aishiliang).

The National Medical Products Administration (NMPA) issued a notice concerning a voluntary recall initiated by Johnson & Johnson International c/o European Logistics Centre for its non-absorbable sutures (trade name: Ethibon/Esiebon). This recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., began on December 23, 2010. The primary reason for the recall was the discovery of potential packaging defects in certain batches manufactured between September and December 2010. These defects could compromise the product packaging seal, thereby failing to guarantee the necessary sterilization standards for medical devices. The affected products included two specific models and two batches, with 3 boxes identified in China out of 54 boxes produced globally or imported into the country. Under the NMPA's framework for medical device safety, Johnson & Johnson was required to contact distributors and hospitals to ensure the return of all recalled products. The company committed to arranging for the collection of these items and offering replacements or compensation for all returned products, emphasizing adherence to crucial product integrity and sterility requirements.