China NMPA Product Recall - Peritoneal dialysis machine

Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its peritoneal dialysis machines, identified under Registration No.: CFDA Approval No. 20122453672. The recall, reported on August 29, 2017, to the National Medical Products Administration (NMPA), addresses a product issue where incorrect opening of the tubing packaging could lead to a cartridge breakage. This action by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. falls under the regulatory oversight of the NMPA and is a proactive measure to manage potential product malfunctions. The company is responsible for providing detailed information on affected models, specifications, and batch numbers through a Medical Device Recall Event Report Form. This recall aims to mitigate risks associated with the reported issue and uphold product safety standards.