OriGen Biomedical voluntarily recalled a lot of its 51 VV13F Reinforced Dual Lumen ECMO Catheters, according to the company and the FDA.
The recall pertains to catheters manufactured on Sept. 22, 2014 and distributed from Feb. 16 to March 26, 2015.
The company said it found the clear extension tube could separate from the hub it is inserted in, which could lead to an intervention to prevent impairment and damage. There was one product failure that caused a serious injury, according to OriGen Biomedical.
The recalled catheters were distributed to Neonatal Intensive Care and Pediatric Intensive Care ECMO centers in California, Texas, Pennsylvania, Michigan, Indiana, Hawaii, Ohio, New York, Kentucky, Oregon and Florida.