China NMPA Product Recall - Diagnostic/ablation adjustable elbow catheter (trade name: Thermocool SF)

On November 28, 2019, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., in conjunction with manufacturer Biosense Webster, Inc., initiated a voluntary Class III recall of its Diagnostic/Ablation Adjustable Elbow Catheter, known by the trade name Thermocool SF. This action stemmed from a non-compliance issue regarding the product's Chinese instruction manual. A specific batch of these devices lacked essential environmental protection information, which is a mandatory requirement under Chinese regulations. Specifically, this omission violated clause 6.8.2j of the GB9706.1-2007 standard for Medical Electrical Equipment Part 1: General Safety Requirements. The National Medical Products Administration (NMPA) oversees this regulatory framework, ensuring medical devices adhere to national standards. While specific inspection dates were not provided, the company voluntarily reported this deficiency, leading to the recall announcement on the aforementioned date. The required action is a comprehensive recall of the affected products to ensure full compliance with regulatory mandates and to provide complete user information, thereby maintaining product integrity and safety standards.