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On May 2, 2007 the FDA issued a formal demand of Shelhigh, Inc. to recall all of its medical devices due to concern of contamination. On April 17, 2007 the FDA requested a voluntary recall by Shelhigh, Inc., after a seizure operation by the U.S. Marshals, but the company refused. The FDA requested that the U.S. Marshals seize any devices and components from Shelhigh's Union, New Jersey facility. The seizure was prompted by the discovery of significant deficiencies in the company's manufacturing process.
The FDA sent two warning letters prior to the official seizing of their property and even after requesting a voluntary recall, the company refused. If they are to refuse the most recent order for recall, the FDA can seek a court order mandating the recall.
It is unfortunate that it takes so much convincing for a company to recall its products, when they have been proven to be unsafe. For a company that manufacturers medical devices which are placed in sick and injured patients' hearts, it is highly alarming that they would put up such a fight after learning their products were doing more harm than good.
In an earlier inspection from the FDA of Shelhigh's New Jersey plant, they found "a number of sterility test failures". They put out a warning to doctors informing them that the way the devices were manufactured may have "contaminated" the devices with "bacteria, fungi or endotoxin."
The marketing director of Shelhigh, Inc., Douglas Goldman, stated that the FDA had no proof or data to justify the demand and therefore "no recall is in effect".
The following is a list of products manufactured and distributed by Shelhigh, Inc. These products are used for open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
- Shelhigh BioRingT (annuloplasty ring)
- Shelhigh GoldT perforated patches
- Shelhigh Internal Mammary Artery
- Shelhigh No-React Dura Shield
- Shelhigh No-React EnCuff Patch
- Shelhigh No-React Pericardial Patch
- Shelhigh No-React PneumoPledgets
- Shelhigh No-React VascuPatch
- Shelhigh No-React Stentless Valve Conduit
- Shelhigh No-React Tissue Repair Patch/UroPatchT
- Shelhigh Pericardial Patch
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh Pulmonic Valve Conduit No-React Treated
- Shelhigh BioConduitT stentless valve
- Shelhigh BioMitralT tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
- Shelhigh MitroFast Mitral Valve Repair System
- Shelhigh NR2000 SemiStentedT aortic tricuspid valve
- Shelhigh NR900A tricuspid valve
- Endura No-React Dural Substitute*
*(Note: This is a private label device. Shelhigh, Inc. manufactured it. Integra Corp. marketed it.)
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