China NMPA Product Recall - Implantable infusion port type central venous catheter and kit
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The National Medical Products Administration (NMPA) announced on October 21, 2019, a voluntary Class II recall initiated by Bard Access Systems, Inc., concerning implantable port-type central venous catheters and kits. This recall was reported by Bard Medical Technology (Shanghai) Co., Ltd. The main issue identified was that certain product packages contained missing or mismatched tunneling devices, which could compromise proper use and patient safety. Under the regulatory oversight of the NMPA, Bard Access Systems, Inc. is required to identify and retrieve all affected product models, specifications, and batches, detailed in the accompanying "Medical Device Recall Event Report Form." This action highlights the manufacturer's commitment to addressing product deficiencies in compliance with NMPA standards, ensuring the integrity and safety of medical devices in the market.
- Company
- Bard Access Systems, Inc.
ID · f50cdb47-8de7-4de6-a018-df7f82cd4aef