China NMPA Product Recall - bidirectional guiding sheath

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing manufacturer Greatbatch Medical, initiated a voluntary Class II recall for specific batches of its bidirectional guiding sheaths (models D140010 and D140011). These medical devices are critical for inserting cardiovascular catheters into the heart. The company first reported the issue in March 2017, providing an updated report on June 9, 2017, with the recall publicly announced by the National Medical Products Administration (NMPA) on July 19, 2017, under Index No.: JGXX-2017-10656.

The main issue identified was that one side of the product's sterile packaging bag was not properly sealed, which could compromise its sterile barrier. The integrity of this barrier is paramount for devices used in invasive procedures to prevent potential infections. In response, Johnson & Johnson (Shanghai) undertook immediate corrective actions: halting all shipments, isolating affected inventory, and notifying customers to cease use and return the products. Following collection and verification, the company committed to destroying all recalled units. This coordinated effort underscores the company's commitment to patient safety and regulatory compliance under NMPA oversight.