Medical device recall

The FDA issued a formal written request to Shelhigh, Inc. to recall all of its medical devices still in the marketplace, including hospital inventories, due to questions about sterility [more].

On April 17, 2007, all medical devices, including components at Shelhigh’s Union, N.J. facility, were seized after the FDA found significant deficiencies in the company’s manufacturing process. At that time, Shelhigh was asked to voluntarily recall its products, but the firm declined.

Shelhigh devices are used to treat infants, children, and adults. Products include pediatric heart valves, conduits for blood flow, surgical patches, dural patches, annuloplasty rings, and arterial grafts.

Adverse reactions or quality problems experienced with any of these products may be reported to FDA’s Medwatch Adverse Event reporting program either online at www.fda.gov/medwatch/report.htm, fax 800-332-01788, or mail. A postage paid form 3500, is available for download at www.fda.gov/MedWatch/getforms.htm