China NMPA Product Recall - Vascular closure system

Abbott Medical Devices Trading (Shanghai) Co., Ltd., representing Abbott Laboratories and Abbott Vascular Inc., initiated a voluntary Class II recall for its Vascular Closure System. This recall was reported on February 13, 2017, and published by the National Medical Products Administration (NMPA) on March 17, 2017. The core issue identified was that specific batches of the Vascular Closure System products (part number 14679 across numerous lot numbers) might encounter difficulty or complete failure in releasing the closure clip. This defect carries potential risks, such as prolonged hospital stays, the necessity for additional medical instruments, or manual pressure to achieve hemostasis. Despite these potential risks, the company reported no instances of long-term or irreversible patient effects. Under the regulatory framework of the NMPA and reporting to the Shanghai Food and Drug Administration, Abbott implemented several required actions. These included identifying and notifying affected customers, requesting confirmation of unused product quantities, arranging for the return of all unused devices, verifying returned quantities, isolating products in designated storage, and awaiting manufacturer instructions for final disposal, either through return or local destruction.