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, as reported to the National Medical Products Administration (NMPA) on February 13, 2017. The recall stems from a critical issue where affected products may experience difficulty or complete failure in releasing the closure clip. This malfunction poses potential risks, including extended hospital stays for patients, the necessity for additional medical instruments, or manual pressure to achieve hemostasis. However, no long-term or irreversible patient effects have been reported.Under the guidance of the NMPA, Abbott's required actions include a comprehensive plan to mitigate risks. The company is identifying all affected customers through shipping records and has reported the recall to the Shanghai Food and Drug Administration. Key steps involve notifying recipients of affected products, requesting return receipts, and ensuring customers confirm and report the quantity of unused products. Subsequently, customers are instructed to return these items. Abbott will verify the returned quantities against declared figures and isolate all affected inventory in dedicated storage. Final disposition, whether return to the manufacturer or local destruction, awaits further instruction from Abbott Laboratories. This recall impacts 14,679 units sold in China across various batches.