China NMPA Product Recall - Disposable human arterial blood sample collection device

Radiometer Medical Devices (Shanghai) Co., Ltd. initiated a Class II voluntary recall for its Disposable Human Arterial Blood Sample Collectors. This action, publicly announced by the National Medical Products Administration (NMPA) on December 2, 2014, was prompted by the discovery of an unidentified brown substance on the surface of some product needles. The affected devices, used for collecting and storing arterial blood samples for blood gas analysis, were identified under Registration Certificate No. CFDA (Imported) No. 20133664963. The recall specifically targeted models LM-52 and 956-529, with 10 boxes of these products having been imported into China. The company, Radiometer Medical Devices (Shanghai) Co., Ltd., reported this issue on November 19, 2014. As part of the required corrective actions under NMPA oversight, the company was mandated to notify all its customers about the quality concern. Customers were instructed to thoroughly check their existing inventory and promptly return any identified affected products. This voluntary recall emphasizes the critical need for robust quality control measures within the medical device industry to maintain product integrity and safeguard patient well-being.