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Shelhigh RecallOn April 17, 2007, U.S. Marshals, at The U.S. Food and Drug Administration?s
(FDA) 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. May 2, 2007 FDA issued a formal written
request to Shelhigh, Inc. to recall all of its medical devices remaining in the
marketplace, including hospital inventories, because of sterility concerns. The
environmental controls and processes used to manufacture and test devices within
the Shelhigh facility was found to compromise the sterility and safety of their
products, and there was therefore a reasonable probability that use of such products
would cause serious adverse health consequences or death. The products to recall
include:- Shelhigh Pericardial Patch
- Shelhigh No-React® Pericardial Patch
- Shelhigh No-React® EnCuff
- Shelhigh No-React® Dura Shield (also sold as Endura[tm] No-React® Dural Substitute by Integra LifeSciences)
- Shelhigh No-React® Tissue Repair Patch/UroPatch{tm]
- Shelhigh No-React® VascuPatch[tm]
- Shelhigh No-React® PneumoPledgets
- Shelhigh No-React® Nulmonic Valve Conduit Models NR-4000/NR-4000PA/NR4000PA-C
- Shelhigh No-React® Stentless Valve Conduit Models NR2000/NR2000+/NR2000C+/NR2000C
- Shelhigh Internal Mammary Artery (SIMA)
- Shelhigh Gold[tm] perforated patch
- 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
If you or a loved one have used or had complications due to the use of any of these Shelhigh products please fill out the form below.
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