Those Harmed by Shelhigh Devices May Speak With an Attorney at our Law Firm

Weitz and Luxenberg is no longer accepting Shelhigh cases.

The U.S. Food and Drug Administration (FDA) issued a formal written request to Shelhigh, Inc. in May 2007 to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns. Numerous patients who were harmed by the tainted devices have come forward to speak with an attorney at our firm.

On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. 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.

FDA recommends that doctors and hospitals consider using alternative products.

"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 and Radiological Health.

"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.

If you were implanted with one of these devices and experienced an injury, a Shelhigh attorney from our firm may be able to assist you. Please complete the form below for a free legal review of your potential case. A representative will be in touch as soon as possible.

see also:

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