FDA requests recall of all Shelhigh medical devices.

FDA issued a formal written request to Shelhigh to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

On April 17, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, NJ facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.

"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, FDA's Center for Devices. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

The company's deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices.

Shelhigh's own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

Shelhigh devices are used in infants, children and adults. The products 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.

FDA is recommending that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html <http://www.fda.gov/cdrh/safety/041907shelhigh.html>

A more-detailed article about the Shelhigh recall will appear in the May issue of Inspection Monitor -the only newsletter that analyzes 483s and EIRs for FDA inspections of drugs, devices and biologicals. For a free sample issue, please email us at [e-mail] or call [phone]