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Company refuses FDA request for recall
On May 2, the Food and Drug Administration (FDA) issued a formal request that Shelhigh in Union, NJ, recall all of its medical devices, including hospital inventories, because of sterility concerns. Shelhigh has responded that it will not initiate a recall.
"This is the first formal request by the FDA for Shelhigh to recall its products; and since the FDA allegations are unfounded, Shelhigh has no intention to initiate a product recall," says Shlomo Gabbay, MD, founder of Shelhigh.
FDA investigators and U.S. marshals seized all implantable medical devices from Shelhigh on April 17 after finding significant deficiencies in the company's manufacturing processes. The agency recommends that doctors and hospitals consider using alternative products.
The products include surgical patches as well as pediatric heart valves and conduits, dural patches, annuloplasty rings, and arterial grafts. Brand names include No-React Tissue Repair Patch/UroPatch, No-React EnCuff Patch, and Gold perforated patches.
FDA has prepared a document for physicians (www.fda.gov) that advises them to monitor patients with a Shel-high implant for infections.
If you have questions, contact the Office of Surveillance and Biometrics (HFZ-510), Rockville, MD. Phone: (240) 276-3357. Fax: (240) 276-3356. E-mail: firstname.lastname@example.org.