China NMPA Product Recall - retaining ring

Radiometer Medical Devices (Shanghai) Co., Ltd., representing manufacturer Radiometer Basel AG, initiated a Class II voluntary recall of its Fixation Rings. This action, published by the National Medical Products Administration (NMPA) on July 23, 2015, addressed a significant quality defect in medical devices registered under NMPA Medical Device (Import) No. 2012 1213424. The primary issue identified was that a small portion of the backing paper's surface coating adheres to the fixation ring upon peeling, resulting in compromised adhesion. This defect can lead to air leakage or detachment of the ring during patient monitoring, thereby affecting the accuracy and reliability of results when the product is used with transcutaneous transluminal radiometers. The recall encompasses various models and batches sold in multiple regions, including the USA, Canada, Europe, Australia, New Zealand, and China. Under NMPA guidance, Radiometer Medical Devices (Shanghai) Co., Ltd. mandated that distributors inspect their own and their customers' inventories, discard any affected products immediately, and committed to providing free replacements to ensure patient safety and compliance with medical device quality standards.