China NMPA Product Recall - Peritoneal dialysis catheters and accessories

On August 13, 2019, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall concerning specific batches of peritoneal dialysis catheters and accessories. The company reported that during routine "flow rate" testing, two batches of these critical medical devices, which it distributes for manufacturer Medcon Co., Ltd., yielded results that did not align with the product's technical requirements. Specifically, the observed "flow rate" test values were higher than the established industry standard. Although Baxter Medical Products Trading (Shanghai) Co., Ltd. stated that these elevated flow rates were not anticipated to negatively impact the product's intended function or compromise patient safety, the decision to recall was made to ensure strict adherence to Chinese regulatory standards. This action was conducted under the oversight of regulatory bodies including the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall encompassed products identified by Registration Certificate No.: 国械注进20163451602. Further specifics regarding the affected models, specifications, and batch numbers were made available through an attached "Medical Device Recall Event Report Form." This proactive measure demonstrates the company's commitment to maintaining compliance within the regulatory framework governing medical devices in China.