U.S. Food and Drug Administration (FDA) Seized All Medical Products From New Jersey Device Manufacturer

Beth Janicek

Attorney
(866) 735-1102 Ext 395

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On April 17, 2007, the FDA investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc. They found finding significant deficiencies in the company's manufacturing processes and the deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.