China NMPA Product Recall - Partially sterilized products

Shanghai Shangyi Kangge Medical Equipment Co., Ltd. initiated a Level II voluntary recall of several sterilized medical devices, as reported to the National Medical Products Administration (NMPA) on September 26, 2016, and publicly announced on December 7, 2016. The recall stems from a critical lapse in quality control. Following a control software update and sterilization parameter adjustments to their Putuo Sterilization Cabinet starting July 25, 2016, the company failed to reconfirm the revised sterilization process. This oversight means the sterility of affected products, despite initial chemical indicator and bacterial tablet inspections, could not be guaranteed, raising potential infection risks for patients. In response, Shanghai Shangyi Kangge Medical Equipment Co., Ltd. has taken several corrective actions. They proactively recalled all impacted product batches and immediately suspended the use of the Putuo sterilizer to undertake a comprehensive parameter reconfirmation. Furthermore, customers were promptly notified to cease using and isolate any affected unused products. The company also ensured all unsold affected inventory was isolated and sealed, confirming no related adverse events or customer complaints had been received at the time of the report. This action aligns with NMPA's regulatory expectations for medical device safety.