The Food and Drug Administration on May 2 issued a formal request that Shelhigh Inc. recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns. On April 17, U.S. Marshals seized all medical devices and components at Shelhigh’s facility in Union, NJ, after the FDA found significant deficiencies in the company’s manufacturing processes.
According to the FDA, the company declined to perform a voluntary recall at that time. The agency recommends that doctors and hospitals consider using alternative products.
The Shelhigh devices include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.
"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. For more information, see the FDA news release.
[ via AHA News Now ]