China NMPA Product Recall - Disposable drainage catheter kits and accessories

The National Medical Products Administration (NMPA) issued an announcement on August 21, 2024, regarding a voluntary Class II recall initiated by Boston Scientific Corporation. This recall was formally reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. and pertains to their single-use Flexima Drainage Catheter and Kit, identified under National Medical Device Registration Certificate No. 20173146023.The primary concern leading to this action is the potential for damage to the transparent sterile packaging bag. Such damage could compromise the sterility of the medical device, posing a potential risk of contamination if used in medical procedures.Under the NMPA's regulatory guidelines, Boston Scientific Corporation is proactively addressing this quality issue through a Class II recall. This classification indicates that the use of or exposure to the affected product could cause temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote.It is specified that the particular models, specifications, and batches involved in this recall are detailed in the accompanying 'Medical Device Recall Event Report Form.' Importantly, the document confirms that these specific recalled products were not imported into China, thereby indicating no direct impact on the Chinese domestic market from this recall event.