China NMPA Product Recall - Single-use peripherally inserted central venous catheters and infant umbilical artery and vein catheters

Prodimed Medical Catheter Development Group (France) initiated a voluntary Class II recall of specific medical devices, as reported by the National Medical Products Administration (NMPA) in China. This recall, announced on June 17, 2020, followed an internal discovery in April 2020. The manufacturer found that during the reconfirmation of its ethylene oxide sterilization process, the weight of the sterilization tray was not consistently measured. This procedural lapse could potentially compromise the sterilization efficacy of the affected products.

The recall specifically targets single-use peripherally inserted central catheters (PICC) and infant umbilical artery and vein catheters, which are vital for drug infusion, blood sampling, and neonatal care. Shandong Xinhua Ande Medical Supplies Co., Ltd. managed the recall within China. Under the NMPA's regulatory framework, the required actions include the immediate withdrawal of all corresponding unused product batches from the market. Furthermore, all recalled products are mandated to be destroyed. This action aims to prevent potentially compromised medical devices from reaching patients across affected regions, which include France, the USA, Australia, and China, impacting thousands of units globally.