Prodimed.S.A Recall

On June 17, 2020, Prodimed.S.A (the manufacturer) voluntarily recalled its Peripherally Inserted Central Catheter (国械注进20143036029) and Catheters Ombilicaux (国械注进20153030470), because during the re-validation of the ethylene oxide sterilization process in April, Prodimed. S.A was failed to control the weight of the sterilized tray. This is a Class II recall, for which temporary or reversible health hazards may be or have been caused by the medical device. Many countries, such as France, the US, Australia and China, are all influenced by this recall. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.

Link: http://mpa.shandong.gov.cn/art/2020/6/17/art_101762_9210407.html