China NMPA Product Recall - Pleural cavity and pericardial drainage kit

Cook Incorporated initiated a voluntary Class II recall for specific batches of its pleural and pericardial drainage kits, as reported to the National Medical Products Administration (NMPA) in April 2019. The core issue identified by the manufacturer is a defect where the catheter tip diameter is smaller than the standard value. This manufacturing deviation can prevent the guidewire from being successfully withdrawn after the drainage catheter has been positioned. Potential patient safety concerns arising from this defect include procedural delays, prolonged intervention times, the need for additional medical procedures, and the risk of organ or vascular damage during catheter manipulation or guidewire removal attempts.

The recall encompasses PCS and C-PCS series products used for pericardial fluid drainage, and C-PPD and C-PPDJ series for draining gas from the pericardial sac or pleural cavity. Significantly, the affected product batches were not distributed or imported into mainland China. Instead, these products were supplied to various international markets, including Australia, Belgium, Canada, France, Germany, Greece, India, Italy, South Korea, Oman, Saudi Arabia, Switzerland, UAE, USA, and Hong Kong, China. As such, Cook (China) Medical Trading Co., Ltd. confirmed that no direct corrective actions or product retrieval measures are required within mainland China, while Cook Incorporated undertakes international corrective actions.