China NMPA Product Recall - bidirectional guiding sheath

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall of its Bidirectional Guiding Sheath products, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. The company identified a critical quality issue where certain product batches exhibited improper sealing on one side of their packaging bags. This manufacturing defect presents a significant risk of compromising the sterile barrier of the packaging, which is essential for patient safety during medical procedures. The potential breach of sterility is a serious concern, as it could expose patients to contamination risks if the devices are used. In response to this finding, Johnson & Johnson proactively decided to recall the affected products to mitigate potential health hazards. Specific details regarding the models, specifications, and batch numbers of the recalled devices are documented in the "Medical Device Recall Event Report Form." This action underscores the company's commitment to product safety and compliance with medical device regulations overseen by the NMPA. The recall aims to prevent any further distribution or use of non-sterile products, ensuring public health protection.