China NMPA Product Recall - Cell separator accessories

On April 30, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall for specific cell separator accessories. This action followed user reports indicating that six units of these medical devices displayed purple ethylene oxide sterility indicators. These indicators are designed to change color, typically to green, after successful exposure to ethylene oxide during the sterilization process. The presence of purple indicators suggests a potential compromise in the sterilization integrity of the products or an issue with the indicator's functionality, thereby raising concerns about the sterility status of the affected accessories. The recall is conducted under the regulatory guidance of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The affected products are identified under Registration Certificate No. 20173407131. GE Healthcare has provided a "Medical Device Recall Event Report Form" detailing specific models, specifications, and batch numbers to facilitate the efficient execution of the recall and ensure ongoing patient safety and product quality.