China NMPA Product Recall - Central venous catheter kits; Central venous catheter kits for hemodialysis (trade name: Mahurkar triple-lumen hemodialysis catheter); Curved double-lumen central venous catheter kits for hemodialysis; Central venous catheter kits for hemodialysis

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of several central venous catheter kits, as announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on May 21, 2019. The recall primarily affects Central Venous Catheter Kits, Central Venous Catheter Kits for Hemodialysis (including the Mahurkar Triple-lumen Hemodialysis Catheter), and Curved Double-lumen Central Venous Catheter Kits. The critical issue leading to this recall involves discrepancies between the stated and actual pre-filled capacities of the catheter lumens. Specifically, the pre-filled capacity indicated on the tube body and in the accompanying documentation was found to be higher than the actual volume required to properly fill each lumen. This inaccuracy poses a potential risk, necessitating corrective action. The recall notice (2019-114) from the Shanghai FDA prompted Covidien's voluntary action. The Class II classification signifies that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further details on specific models, specifications, and affected batches are available in the "Medical Device Recall Event Report Form." This proactive measure by Covidien, under NMPA oversight, aims to ensure patient safety and product accuracy within the medical device industry.