China NMPA Product Recall - Disposable perineal care kit

Henan Gore Medical Device Co., Ltd. initiated a Class III voluntary recall of its disposable perineal care kits, as reported to the National Medical Products Administration (NMPA) on November 23, 2020. The recall was prompted by a critical manufacturing defect: iodine leakage from the kits caused the internal tweezers to rust. This issue compromised the quality and safety of product batch number 20030702, affecting 1500 units distributed across China. The company formally reported the recall event on January 15, 2020. Under the NMPA's regulatory framework for medical devices, Henan Gore Medical Device Co., Ltd. undertook several required actions. This included issuing a recall notice to all domestic customers who had received the affected batch. However, the report noted that by the time the notices were distributed, the products had already been utilized by the end-users. Crucially, the company has confirmed that it has completed all necessary rectification measures to address the underlying non-conformities, thereby preventing similar defects in future production. This proactive recall highlights the importance of stringent quality control in medical device manufacturing.