April 20, 2022Medical DevicesFDA
Kaneka America Corp recalls LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables
Hazard: Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.