FDA Asks Shelhigh to Recall All Products
After U.S. Marshals seized products, FDA requests recall of all devices from hospitals, physicians
THURSDAY, May 3 (HealthDay News) -- The U.S. Food and Drug Administration has ordered Shelhigh, Inc., of Union, N.J., to recall all of its medical devices due to concerns about sterility related to manufacturing deficiencies. Last month, the FDA and U.S. Marshals seized Shelhigh's pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts.
The latest action requires Shelhigh to retrieve devices already in the market, including items on hospital inventories. Physicians are advised not to use Shelhigh products.
"Since these are critical devices implanted into seriously ill patients, ensuring their sterility is absolutely essential to prevent infection. FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, in a statement.
Physicians concerned about Shelhigh products already in use can view a list of affected products on the FDA's Web site.