Updated June, 2007: Shelhigh Inc. of Union, NJ agreed to a consent order to stop distributing its implantable medical devices until manufactured devices have been corrected and all FDA standards are met.
The devices and components which include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings, and arterial grafts, are thought to be potentially unsterile.
According to the consent order, the company must hire consultants to check the facility and make sure FDA corrections are made. Shelhigh is allowed to continue manufacturing goods, but at this time they cannot distribute their merchandise. If the company violates any part of the consent order or FDA law then manufacturing may be stopped and a recall may be enacted.