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FDA Seizure Uncovers Serious Medical Device Problems

Shelhigh, Inc. is smarting after an FDA seizure that revealed "significant manufacturing violations" in medical devices produced in its New Jersey plant.

FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations

The products were apparently manufactured in an unclean environment that lacked proper sterility controls. Sheligh products 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

Related Links
Medtronic Information at LegalView.com
ResMed recalls sleep apnea devices

Posted by Erin Blakemore on April 25, 2007 12:53 AM |

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