China NMPA Product Recall - Vascular closure system

Abbott Medical Devices Trading (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Vascular Closure System, reported to the National Medical Products Administration (NMPA) on February 13, 2017. The recall stemmed from the discovery that affected product batches might experience difficulty or complete failure in releasing the closure clip. This issue presented potential risks such as prolonged hospital stays, the need for additional instruments, or manual pressure for hemostasis, though no long-term or irreversible patient effects were reported. Under the regulatory framework involving the NMPA and reporting to the Shanghai Food and Drug Administration, Abbott is implementing several required actions. These include identifying affected customers via shipping history, notifying recipients to return unused products, verifying returned quantities, and isolating the products. The company will then await the manufacturer's instructions for product disposal, either through return or local destruction, to ensure patient safety and product integrity.