China NMPA Product Recall - Disposable enteral nutrition bag pump tubing

Condis (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its disposable enteral nutrition bag pump tubes (Registration Certificate No.: 20182661746). This action was reported by the National Medical Products Administration (NMPA) on February 8, 2021, with information originating from the Shanghai Municipal Drug Administration on February 4, 2021. The recall addresses a critical product issue where air can enter the tubing and create a gas barrier. This defect poses a risk of adverse health consequences, including vomiting, dehydration, hypoglycemia, abdominal pain, and bloating in patients. The company identified these potential harms, leading to the immediate recall to mitigate risks. Further details on specific models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form." This proactive measure underscores the NMPA's regulatory commitment to ensuring medical device safety and patient well-being.