China NMPA Product Recall - bidirectional guiding sheath

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Class II recall for its Bidirectional Guiding Sheath, identified by registration code 国核注进20153771320. The recall stemmed from a critical issue where one side of the product packaging bag was not adequately sealed, which could compromise the sterile barrier essential for medical devices. This manufacturing defect posed a potential risk to patient safety due to the loss of product sterility. The company first reported this recall to regulatory authorities in March 2017, and an updated report was submitted on June 9, 2017, after discovering an increased number of affected products within the distribution channel. This action falls under the regulatory framework of the National Medical Products Administration (NMPA). The recall specifically impacts 781 units of the Mobicath Bidirectional Guiding Sheath, including models D140010 and D140011, affecting numerous identified batch numbers. In response, Johnson & Johnson has mandated several corrective actions to manage the recall effectively. These include an immediate halt to all shipments of the affected batches and the isolation of existing inventory. Furthermore, customers who received the potentially compromised products were instructed to cease their use and return them to Johnson & Johnson warehouses. Following a thorough inventory and verification process, all returned items will be destroyed to prevent further use and mitigate any associated health risks.