China NMPA Product Recall - Endoscopic curved needle holder/surgical tissue bag and guide

Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall of its Endoscopic Needle Holder/Surgical Tissue Bag and Importer, as reported by the National Medical Products Administration (NMPA) on June 19, 2017. The recall was prompted by the discovery of insufficient information provided regarding the product's re-cleaning, disinfection, and sterilization processes. This critical oversight could potentially lead to serious patient health risks, specifically infections, if the medical devices were to be reused without proper reprocessing guidance. The affected products include specific models of the Endoscopic Needle Holder/Surgical Tissue Bag and Importer, registered under CFDA (Imported) No. 2013220827 (Revised) and CFDA Import Registration No. 20152772363. This regulatory action, overseen by the NMPA, mandates that Cook (China) Medical Trading Co., Ltd. addresses the identified informational deficiencies and ensures the safe use of its products. The company's proactive recall aims to mitigate potential harm to patients by preventing the improper reprocessing and subsequent reuse of these devices, thereby upholding medical device safety standards. Detailed information regarding specific affected product models is available in the "Medical Device Recall Event Report Form" attachments.