According to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website, OriGen Biomedical recalled one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters. The nationwide recall was initiated because the clear extension tube could potentially separate from the hub in which it is inserted. If this separation occurs, intervention may be needed to prevent permanent impairment or damage.
The recall affects lot N18549, which expires 09/2018. OriGen knows of at least one product failure, which is associated with a serious adverse event that led to a serious patient injury, the recall indicated.
The devices are intended to be used during extracorporeal life support procedures lasting six hours or less in the Neonatal Intensive Care and Pediatric Intensive Care ECMO centers. They are used as a single cannula to re-infuse blood in the internal jugular vein and for venous drainage.
Customers affected by the recall should return the device, the notice indicates. The product was distributed to ECMO sites in the following states: California, Texas, Pennsylvania, Michigan, Indiana, Hawaii, Ohio, New York, Kentucky, Oregon and Florida.
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