WASHINGTON, April 18 (UPI) -- The U.S. Food and Drug Administration has seized what it said were potentially unsafe implantable medical devices manufactured by Shelhigh Inc.
FDA inspectors said they found significant deficiencies in the Union, N.J., company's manufacturing processes that might compromise the safety, particularly sterility and effectiveness of the products.
The seized products include pediatric heart valves and conduits, surgical patches, dural patches and arterial grafts. The tissue-based devices are used in many surgical settings, including open chest surgery and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
The FDA said critically ill patients, pediatric patients and immuno-compromised patients might be at greatest risk from the use of the devices.
Shelhigh is accused of manufacturing products in a facility with a poorly constructed and poorly maintained clean room, failing to adequately monitor its manufacturing environments for possible microbial contamination, failing to properly test products for sterility and failing to scientifically support product expiration dates.
The FDA advised physicians to monitor patients with a Shelhigh implant for infections and proper device functioning.
