China NMPA Product Recall - Fast-Cath Hemostasis Introducer with Hemostatic Valve Catheter Sheath

The National Medical Products Administration (NMPA) published a notice on January 20, 2020, concerning a voluntary Class III recall initiated by St. Jude Medical, distributed by Abbott Medical Products (Shanghai) Co., Ltd. This recall addresses the Fast-Cath Hemostasis Introducer with a hemostatic valve, a medical device registered under Certificate No.: 20143035569.

The core issue necessitating this recall is the incorrect assembly of the sheath/dilator components and deficiencies in the associated instructions. This manufacturing non-conformance represents a potential product quality concern requiring immediate corrective action. The NMPA serves as the overseeing regulatory authority for this action; however, specific inspection dates leading to this recall are not detailed within the document.

A Class III recall typically indicates that the use of or exposure to the affected product is not likely to cause serious adverse health consequences. St. Jude Medical, as the manufacturer, is taking responsibility by voluntarily withdrawing the affected units from distribution. The required actions involve the removal of these devices from the market. Comprehensive information, including specific product models, specifications, and batch numbers impacted by this recall, is provided in an attached 'Medical Device Recall Event Report Form' to facilitate effective product retrieval and management, aiming to uphold medical device safety standards.