Implantable Devices Seized Over Safety Concerns

US marshals and investigators with the Food and Drug Administration seized all implantable medical devices from Shelhigh, Inc. after the Union, NJ plant was inspected last fall. Officials had warned the company in letters sent in 2000 and 2005 about the safety and effectiveness, including sterility of the implantable medical devices prior to seizing them. The plant was processing the devices for pediatric heart valves and conduits, or tube-like devices for blood flow, as well as surgical patches, arterial grafts and annuloplasty rings. Violations cited by the FDA included the processing of these products in a room that was poorly constructed and poorly maintained.