FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Violations
Posted: Tuesday, June 5th 2007
(April 18, 2007) U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.
Medical devices manufactured by Shelhigh include:
- Shelhigh Pericardial Patch
- Shelhigh No-React Pericardial Patch
- Shelhigh No-React PneumoPledgets
- Shelhigh No-React VascuPatch
- Shelhigh No-React Tissue Repair Patch/UroPatch
- Shelhigh Pulmonic Valve Conduit No-React Treated
- Shelhigh No-React Dura Shield
- Shelhigh BioRing (annuloplasty ring)
- Shelhigh No-React EnCuff Patch
- Shelhigh No-React Stentless Valve Conduit
- Shelhigh Internal Mammary Artery
- Shelhigh Gold perforated patches
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh NR2000 SemiStented aortic tricuspid valve
- Shelhigh BioConduit stentless valve
- Shelhigh NR900A tricuspid valve
- Shelhigh MitroFast Mitral Valve Repair System
- Shelhigh BioMitral tricuspid valve
- Shelhigh Injectable Pulmonic Valve System