China NMPA Product Recall - Implantable infusion port type central venous catheter and kit

On October 17, 2019, the National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Bard Access Systems, Inc. The recall, reported by Bard Medical Technology (Shanghai) Co., Ltd., pertains to specific batches of implantable port-type central venous catheters and kits (Registration Certificate No.: 20153662708). The primary issue identified was a manufacturing and packaging error resulting in a missing or mismatched tunneling device within the product kits. These devices are crucial for the proper and safe implantation of the catheters. The absence or incorrect component could potentially compromise the surgical procedure, leading to delays, difficulties, or even adverse events for patients. Bard Access Systems, Inc. is proactively recalling the affected products from the market to mitigate any potential risks. Detailed information regarding the specific models, specifications, and batch numbers involved in this recall is available in the "Medical Device Recall Event Report Form." This action highlights the company's commitment to ensuring product quality and compliance with NMPA regulatory standards, safeguarding patient health and safety.