OriGen Biomedical reinforced dual lumen ECMO catheter recall


FDA report “OriGen Biomedical initiated a nationwide recall for one lot (lot N18549, expiration 09/2018) of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen Biomedical is aware of one product failure and has received a complaint associated with the problem. This serious adverse event resulted in a serious patient injury”.

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