Notice of FDA recall of Shelhigh medical devices
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. The FDA has set up a website with preliminary advice for patients that have these implants.
“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.
What can I do if I have been injured as the result of an Shelhigh device?
We are currently investigating claims involving the Shelhigh products named in the FDA recall.
If you or a loved has suffered a serious infection, or their Shelhigh device failed and had to be replaced, you may be entitled to compensation. For a free legal consultation, contact us today!