Medical Devices Seized Over Sterility Concerns

WASHINGTON -- U.S. marshals and Food and Drug Administration investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about sterility.

The seizure from Shelhigh Inc. was expected to net an estimated one million parts and finished products, said FDA spokeswoman Heidi Rebello. The FDA said it had found significant problems in the Union, N.J., company's manufacturing processes.

The federal officials seized all implantable medical devices from the company, saying the problems could compromise their safety and effectiveness, including the sterility of the implants. The products include pediatric heart valves and conduits, or tube-like devices for blood flow, as well as surgical patches, arterial grafts and annuloplasty rings.

The seizure followed an inspection of the company by the FDA in the fall. The agency warned Shelhigh about the problems during meetings and in two warning letters, sent in 2000 and 2005. Violations cited by the FDA included the manufacturing of products in a facility with a poorly constructed and poorly maintained clean room, where sterilized devices are meant to be further processed.

The company didn't return a telephone message seeking comment.

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