China NMPA Product Recall - Blood perfusion device and tubing

Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of specific hemoperfusion devices and tubing accessories, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on June 20, 2019. This action was prompted by customer complaints detailing an issue where tubing became kinked during treatment with continuous blood purification equipment. The primary concern stemming from this kinking is compromised blood flow, which can trigger alarms in the control unit. Such interruptions may necessitate the halting of treatment and the replacement of the affected kit consumables, posing a potential risk to patient care and operational efficiency. The affected products, bearing Registration Certificate No. 20143455621, involve six distinct items, with detailed specifications and batch information provided in an accompanying Medical Device Recall Event Report Form. This recall falls under the regulatory oversight of the NMPA, which hosts the official announcement, reflecting a commitment to medical device safety and quality assurance within the Chinese market. Baxter's proactive measure aims to address the reported performance issue and ensure the reliability of its medical supplies. The recall notification was formally issued as Shanghai Food and Drug Administration Medical Device Recall 2019-145.