China NMPA Product Recall - Vascular sheath, guidewire, drainage catheter, insertion device, biliary drainage catheter

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Cook Incorporated, as reported by Cook (China) Medical Trading Co., Ltd., on May 29, 2025. The core issue driving this recall is the absence of accompanying paper instructions for certain medical products, a violation concerning complete product documentation. The recall impacts several critical medical devices, including various vascular sheaths such as Flexor Check-Flo I Sets and Flexor Tuohy-Borst Si Introducers, as well as guidewires, drainage catheters, and biliary drainage catheters. Each of these products is identified by specific National Medical Device Registration Certificates. The regulatory framework under which this action takes place is the NMPA, which oversees medical device safety and compliance in China. Required actions involve the voluntary recall of the identified products, with specific models, specifications, and batch numbers detailed in an attached "Medical Device Recall Event Report Form." A Class III recall indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences, yet proper documentation is crucial for safe and effective use. This action underscores the NMPA's stringent requirements for medical device labeling and documentation.