China NMPA Product Recall - bidirectional guiding sheath

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its bidirectional guiding sheath (Note: 20153771320), as announced on July 14, 2017, by the National Medical Products Administration (NMPA). The recall was prompted by the discovery that one side of the product's packaging bag was not properly sealed. This manufacturing defect raised concerns about the integrity of the sterile barrier, potentially compromising the sterility of the medical device and posing a risk to patient safety. The company proactively reported the issue and took corrective action by recalling the affected products. Detailed information regarding specific models, specifications, and batch numbers was provided in the accompanying "Medical Device Recall Event Report Form" attachments. This action underscores the regulatory framework's commitment to ensuring the safety and quality of medical devices available in the market.