China NMPA Product Recall - Epidural Catheters Sets and Kits

On August 18, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Arrow International, Inc. concerning their Epidural Catheters Sets and Kits (Registration Certificate No.: 20163660685). The recall was reported by Telefel Medical Devices Trading (Shanghai) Co., Ltd., the local agent. The primary issue identified was incorrect labeling on specific product models and batches, which resulted in an erroneous display of the expiration date. This critical labeling error could lead to healthcare professionals inadvertently using expired devices, thereby increasing the risk of patient complications. As a corrective action, Arrow International, Inc. is conducting a voluntary recall of the affected products to mitigate potential health risks associated with the mislabeled expiration dates and ensure patient safety within the NMPA's regulatory framework.