China NMPA Product Recall - Vascular sheathFlexor Check-Flo Introducer Sets

On November 18, 2021, medical device manufacturer Cook Incorporated initiated a voluntary Class II recall for its Flexor Check-Flo Introducer Sets. This recall was reported by Cook (China) Medical Trading Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) of China. The primary reason for the recall was a critical discrepancy between the label on the product packaging and the actual medical device contained within, affecting a specific model and batch. This labeling inaccuracy could potentially lead to the use of an incorrect device, posing risks to patient safety. Operating under the regulatory framework of the NMPA, the manufacturer took proactive responsibility by undertaking this voluntary recall. A Class II recall indicates a situation where exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The required action involves removing the affected Flexor Check-Flo Introducer Sets from circulation, with further details on impacted models and batches available in a separate 'Medical Device Recall Event Report Form'.